§ 379j. Authority to assess and use device fees

Footnotes

1. 1 See References in Text note below.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Medical Device User Fee and Modernization Act of 2002

   Pub. L. 107–250 title I § 102(a) · 116 Stat. 1588

   Enacted · 21 U.S.C. § 379j

   June 25, 1938, ch. 675, § 738, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1591

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 738, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1591

   Enacted provision · exact public law section
   (a) In General.— Subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379F et seq.) is amended by adding at the end the following part: “PART 3— FEES RELATING TO DEVICES “SEC. 737. DEFINITIONS. “For purposes of this subchapter: “(1) The term ‘premarket application’ means— “(A) an application for approval of a device submitted under section 515(c) or section 351 of the Public Health Service Act; or “(B) a product development protocol described in section 515(f). Such term does not include a supplement, a premarket report, or a premarket notification submission. “(2) The term ‘premarket report’ means a report submitted under section 515(c)(2). “(3) The term ‘premarket notification submission’ means a report submitted under section 510(k). “(4) (A) The term ‘supplement’, with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which— “(i) an application or report has been approved under section 515(d), or an application has been approved under section 351 of the Public Health Service Act; or “(ii) a notice of completion has become effective under section 515(f). “(B) The term ‘panel-track supplement’ means a supplement to an approved premarket application or premarket report under section 515 that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness. “(C) The term ‘180-day supplement’ means a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling. “(D) The term ‘real-time supplement’ means a supplement to an approved premarket application or premarket report under section 515 that requests a minor change to the device, such as a minor change to the design of the device, software, manufacturing, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement. “(E) The term ‘efficacy supplement’ means a supplement to an approved premarket application under section 351 of the Public Health Service Act that requires substantive clinical data. “(5) The term ‘process for the review of device applications’ means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, and premarket notification submissions: “(A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions. “(B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval. “(C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements. “(D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, and submissions. “(E) Review of device applications subject to section 351 of the Public Health Service Act for an investigational new drug application under section 505(i) or for an investigational device exemption under section 520(g) and activities conducted in anticipation of the submission of such applications under section 505(i) or 520(g). “(F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, and premarket notification submissions. “(G) The development of voluntary test methods, consensus standards, or mandatory performance standards under section 514 in connection with the review of such applications, reports, supplements, or submissions and related activities. “(H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, or submissions. “(I) Any activity undertaken under section 513 or 515(i) in connection with the initial classification or reclassification of a device or under section 515(b) in connection with any requirement for approval of a device. “(J) Evaluation of postmarket studies required as a condition of an approval of a premarket application under section 515 or section 351 of the Public Health Service Act. “(K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, or premarket notification submissions. “(6) The term ‘costs of resources allocated for the process for the review of device applications’ means the expenses incurred in connection with the process for the review of device applications for— “(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors; “(B) management of information, and the acquisition, maintenance, and repair of computer resources; “(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and “(D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, and submissions. “(7) The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for April of the preceding fiscal year divided by such Index for April 2002. “(8) The term ‘affiliate’ means a business entity that has a relationship with a second business entity if, directly or indirectly— “(A) one business entity controls, or has the power to control, the other business entity; or “(B) a third party controls, or has power to control, both of the business entities. “SEC. 738. AUTHORITY TO ASSESS AND USE DEVICE FEES. “(a) Types of Fees.— Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002, the Secretary shall assess and collect fees in accordance with this section as follows: “(1) Premarket application, premarket report, supplement, and submission fee.— “(A) In general.— Except as provided in subparagraph (B) and subsection (d), each person who submits any of the following, on or after October 1, 2002, shall be subject to a fee established under subsection (c)(5) for the fiscal year involved in accordance with the following: “(i) A premarket application. “(ii) For a premarket report, a fee equal to the fee that applies under clause (i). “(iii) For a panel track supplement, a fee equal to the fee that applies under clause (i). “(iv) For a 180-day supplement, a fee equal to 21.5 percent of the fee that applies under clause (i), subject to any adjustment under subsection (c)(3). “(v) For a real-time supplement, a fee equal to 7.2 percent of the fee that applies under clause (i). “(vi) For an efficacy supplement, a fee equal to the fee that applies under clause (i). “(vii) For a premarket notification submission, a fee equal to 1.42 percent of the fee that applies under clause (i), subject to any adjustment under subsection (c)(3) and any adjustment under subsection (e)(2)(C)(ii). “(B) Exceptions.— “(i) Humanitarian device exemption.— An application under section 520(m) is not subject to any fee under subparagraph (A). “(ii) Further manufacturing use.— No fee shall be required under subparagraph (A) for the submission of a premarket application under section 351 of the Public Health Service Act for a product licensed for further manufacturing use only. “(iii) State or federal government sponsors.— No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, or premarket notification submission submitted by a State or Federal Government entity unless the device involved is to be distributed commercially. “(iv) Premarket notifications by third parties.— No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 523. “(v) Pediatric conditions of use.— “(I) In general.— No fee shall be required under subparagraph (A) for a premarket application, premarket report, or premarket notification submission if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population. “(II) Subsequent proposal of adult conditions of use.— In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application. “(C) Payment.— The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and the date of the enactment of the Medical Device User Fee and Modernization Act of 2002 shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 515(c)(3) shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003. “(D) Refunds.— “(i) Application refused for filing.— The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application or supplement that is refused for filing. “(ii) Application withdrawn before filing.— The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application or supplement that is withdrawn prior to the filing decision of the Secretary. “(iii) Application withdrawn before first action.— After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement. The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable. “(b) Fee Revenue Amounts.— Except as provided in subsections (c), (d), (e), (g), and (h), the fees under subsection (a) shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; $29,785,000 in fiscal year 2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007. If legislation is enacted after the date of the enactment of the Medical Device User Fee and Modernization Act of 2002 requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications. “(c) Adjustments.— “(1) Inflation adjustment.— The revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of— “(A) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average) for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or “(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia. The adjustment made each fiscal year by this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2003 under this subsection. “(2) Workload adjustment.— After the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall, beginning with fiscal year 2004, be adjusted further each fiscal year to reflect changes in the workload of the Secretary for the process for the review of device applications. With respect to such adjustment: “(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of premarket applications, investigational new device applications, premarket reports, supplements, and premarket notification submissions submitted to the Secretary. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies. “(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues for the fiscal year established in subsection (b), as adjusted for inflation under paragraph (1). “(3) Compensating adjustment.— After the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), and for workload in accordance with paragraph (2), the fee revenues shall, beginning with fiscal year 2004, be adjusted further each fiscal year, if necessary, to reflect the cumulative amount by which collections for previous fiscal years, beginning with fiscal year 2003, fell below the cumulative revenue amounts for such fiscal years specified in subsection (b), adjusted for such fiscal years for inflation in accordance with paragraph (1), and for workload in accordance with paragraph (2). “(4) Final year adjustment.— For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fees and fee revenues established in subsection (b) if such adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of device applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover user fee balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made. “(5) Annual fee setting.— The Secretary shall, 60 days before the start of each fiscal year after September 30, 2002, establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustment provided under this subsection and subsection (e)(2)(C)(ii), Federal Register, publication. except that the fees established for fiscal year 2003 shall be based on a premarket application fee of $154,000. “(6) Limit.— The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications. “(d) Small Businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval Fees.— “(1) In general.— The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vi) of subsection (a)(1)(A) may be paid at a reduced rate in accordance with paragraph (2)(C). “(2) Rules relating to premarket approval fees.— “(A) Definition.— “(i) In general.— For purposes of this subsection, the term ‘small business’ means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms. “(ii) Adjustment.— The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold. “(B) Evidence of qualification.— An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for a waiver of the fee or the lower fee rate. The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, partners, and parent firms. which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, partners, and parent firms, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively. “(C) Reduced fees.— Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(5) may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement. “(D) Request for fee waiver or reduction.— An applicant seeking a fee waiver or reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a waiver or reduction is not reviewable. “(e) Small Businesses; Fee Reduction Regarding Pre-market Notification Submissions.— “(1) In general.— Where the Secretary finds that the applicant involved is a small business, the fee specified in subsection (a)(1)(A)(vii) may be paid at a reduced rate in accordance with paragraph (2)(C). “(2) Rules relating to premarket notification submissions.— “(A) Definition.— For purposes of this subsection, the term ‘small business’ means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms. “(B) Evidence of qualification.— An applicant shall pay the higher fees established by the Secretary each year unless the applicant submits evidence that it qualifies for the lower fee rate. The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, partners, and parent firms, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, partners, and parent firms, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively. “(C) Reduced fees.— “(i) In general.— Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 80 percent of the fee that applies under subsection (a)(1)(A)(vii), as adjusted under clause (ii) and as established under subsection (c)(5). “(ii) Adjustment per fee revenue amount.— For fiscal year 2004 and each subsequent fiscal year, the Secretary, in setting the revenue amount under subsection (c)(5) for premarket notification submissions, shall determine the revenue amount that would apply if all such submissions for the fiscal year involved paid a fee equal to 1.42 percent of the amount that applies under subsection (a)(1)(A)(i) for premarket applications, and shall adjust the fee under subsection (a)(1)(A)(vii) for premarket notification submissions such that the reduced fees collected under clause (i) of this subparagraph, when added to fees for such submissions that are not paid at the reduced rate, will equal such revenue amount for the fiscal year. “(D) Request for reduction.— An applicant seeking a fee reduction under this subsection shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subsection (a). The decision of the Secretary regarding whether an entity qualifies for such a reduction is not reviewable. “(f) Effect of Failure to Pay Fees.— A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person have been paid. “(g) Conditions.— “(1) Performance goals through fiscal year 2005; termination of program after fiscal year 2005.— With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products: “(A) (i) For each of the fiscal years 2003 and 2004, the Secretary is expected to meet all of the goals identified for the fiscal year involved in any letter referred to in section 101(3) of the Medical Device User Fee and Modernization Act of 2002 (referred to in this paragraph as ‘performance goals’) if the amount so appropriated for such fiscal year, excluding the amount of fees appropriated for such fiscal year, is equal to or greater than $205,720,000 multiplied by the adjustment factor applicable to the fiscal year. “(ii) For each of the fiscal years 2003 and 2004, if the amount so appropriated for the fiscal year involved, excluding the amount of fees appropriated for such fiscal year, is less than the amount that applies under clause (i) for such fiscal year, the following applies: “(I) The Secretary is expected to meet such goals to the extent practicable, taking into account the amounts that are available to the Secretary for such purpose, whether from fees under subsection (a) or otherwise. “(II) The Comptroller General of the United States shall submit to the Congress a report describing whether and to what extent the Secretary is meeting the performance goals identified for such fiscal year, and whether the Secretary will be able to meet all performance goals identified for fiscal year 2005. A report under the preceding sentence shall be submitted to the Congress not later than July 1 of the fiscal year with which the report is concerned. “(B) (i) For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of— “(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003; “(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and “(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005. “(ii) For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies: “(I) The Secretary is expected to meet such goals to the extent practicable, taking into account the amounts that are available to the Secretary for such purpose, whether from fees under subsection (a) or otherwise. “(II) The Comptroller General of the United States shall submit to the Congress a report describing whether and to what extent the Secretary is meeting the performance goals identified for such fiscal year, and whether the Secretary will be able to meet all performance goals identified for fiscal year 2006. The report under the preceding sentence shall be submitted to the Congress not later than July 1, 2005. “(C) For fiscal year 2006, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if the total of the amounts so appropriated for fiscal years 2003 through 2006, excluding the amount of fees appropriated for such fiscal years, is less than the sum of— “(i) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2006; and “(ii) an amount equal to the sum that applies for purposes of subparagraph (B)(i). “(D) For fiscal year 2007, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if— “(i) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is less than $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2007; or “(ii) pursuant to subparagraph (C), fees were not assessed under subsection (a) for fiscal year 2006. “(2) Authority.— If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. “(h) Crediting and Availability of Fees.— “(1) In general.— Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications. “(2) Collections and appropriation acts.— “(A) In general.— The fees authorized by this section— “(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year, and “(ii) shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2002 multiplied by the adjustment factor. “(B) Compliance.— The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of device applications— “(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or “(ii) (I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for a subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and “(II) such costs are not more than 5 percent below the level specified in such subparagraph. “(3) Authorization of appropriations.— There are authorized to be appropriated for fees under this section— “(A) $25,125,000 for fiscal year 2003; “(B) $27,255,000 for fiscal year 2004; “(C) $29,785,000 for fiscal year 2005; “(D) $32,615,000 for fiscal year 2006; and “(E) $35,000,000 for fiscal year 2007, as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by application fees. “(4) Offset.— Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year. “(i) Collection of Unpaid Fees.— In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code. “(j) Written Requests for Refunds.— To qualify for consideration for a refund under subsection (a)(1)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due. “(k) Construction.— This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in the process of the review of device applications, be reduced to offset the number of officers, employees, and advisory committees so engaged.”.

2. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(d)(3)(A) · 118 Stat. 572

   Changed · 21 U.S.C. § 379j

   Pub. L. 108–214, § 2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, § 102(a), which enacted this section

   Source evidence

   Code amendment note
   Pub. L. 108–214, § 2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, § 102(a), which enacted this section.

   Enacted provision · exact public law section
   (A) in section 102(a) (116 Stat. 1589), 21 USC 379i, 379j. by striking “(21 U.S.C. 379F et seq.)” and inserting “(21 U.S.C. 379f et seq.)”;

3. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(d)(2)(A) · 118 Stat. 572

   1. Amended · 21 U.S.C. § 379j(a)

      Pub. L. 108–214, § 2(d)(2)(A), designated introductory provisions of subsec. (a) as par. (1)

   2. Inserted · 21 U.S.C. § 379j(a)

      Pub. L. 108–214, § 2(d)(2)(A), inserted heading

   3. Substituted · 21 U.S.C. § 379j(a)

      Pub. L. 108–214, § 2(d)(2)(A), substituted “this section.” for “this section as follows:”

   4. Redesignated · 21 U.S.C. § 379j(a)

      Pub. L. 108–214, § 2(d)(2)(A), redesignated former par. (1) as (2)

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 108–214, § 2(d)(2)(A), designated introductory provisions of subsec. (a) as par. (1), inserted heading, substituted “this section.” for “this section as follows:”, and redesignated former par. (1) as (2).

   Enacted provision · exact public law section
   (A) In general.— Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as amended by subsection (a), is amended— (i) in the matter preceding paragraph (1)— (I) by striking “(a) Types of Fees.—Beginning on” and inserting the following: “(a) Types of Fees.— “(1) In general.— Beginning on” ; and (II) by striking “this section as follows:” and inserting “this section.”; and (ii) by striking “(1) Premarket application,” and inserting the following: “(2) Premarket application,”.

4. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(a)(2)(A)(i) · 118 Stat. 572

   1. Substituted · 21 U.S.C. § 379j(a)(1)(A)

      Pub. L. 108–214, § 2(a)(2)(A)(i), substituted, in introductory provisions, “subsections (d) and (e)” for “subsection (d)”

   2. Substituted · 21 U.S.C. § 379j(a)(1)(A)

      Pub. L. 108–214, § 2(a)(2)(A)(i), substituted, in introductory provisions, “clause (i)” for “clause (i), subject to any adjustment under subsection (c)(3) of this section”

   3. Substituted · 21 U.S.C. § 379j(a)(1)(A)

      Pub. L. 108–214, § 2(a)(2)(A)(i), substituted, in introductory provisions, “clause (i), subject to any adjustment under subsection (e)(2)(C)(ii)” for “clause (i), subject to any adjustment under subsection (c)(3) of this section and any adjustment under subsection (e)(2)(C)(ii)”

   Source evidence

   Code amendment note
   Subsec. (a)(1)(A). Pub. L. 108–214, § 2(a)(2)(A)(i), substituted, in introductory provisions, “subsections (d) and (e)” for “subsection (d)”, in cl. (iv), “clause (i)” for “clause (i), subject to any adjustment under subsection (c)(3) of this section”, and, in cl. (vii), “clause (i), subject to any adjustment under subsection (e)(2)(C)(ii)” for “clause (i), subject to any adjustment under subsection (c)(3) of this section and any adjustment under subsection (e)(2)(C)(ii)”.

   Enacted provision · exact public law section
   (i) in subparagraph (A)— (I) in the matter preceding clause (i) by striking “subsection (d),” and inserting “subsections (d) and (e),”; (II) in clause (iv), by striking “clause (i),” and all that follows and inserting “clause (i).”; and (III) in clause (vii), by striking “clause (i),” and all that follows and inserting “clause (i), subject to any adjustment under subsection (e)(2)(C)(ii).”; and

5. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(a)(2)(A)(ii) · 118 Stat. 572

   Substituted · 21 U.S.C. § 379j(a)(1)(D)(i); 21 U.S.C. § 379j(a)(1)(D)(ii)

   Pub. L. 108–214, § 2(a)(2)(A)(ii), substituted “application, report,” for “application”

   Source evidence

   Code amendment note
   Subsec. (a)(1)(D)(i), (ii). Pub. L. 108–214, § 2(a)(2)(A)(ii), substituted “application, report,” for “application”.

   Enacted provision · exact public law section
   (ii) in subparagraph (D), in each of clauses (i) and (ii), by striking “application” and inserting “application, report,”;

6. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(d)(2)(B)(i) · 118 Stat. 572

   Substituted · 21 U.S.C. § 379j(d)(1)

   Pub. L. 108–214, § 2(d)(2)(B)(i), substituted “subsection (a)(2)(A)” for “subsection (a)(1)(A)” in last sentence

   Source evidence

   Code amendment note
   Subsec. (d)(1). Pub. L. 108–214, § 2(d)(2)(B)(i), substituted “subsection (a)(2)(A)” for “subsection (a)(1)(A)” in last sentence.

   Enacted provision · exact public law section
   (i) in subsection (d)(1), in the last sentence, by striking “subsection (a)(1)(A)” and inserting “subsection (a)(2)(A)”;

7. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(a)(2)(B) · 118 Stat. 572

   Substituted · 21 U.S.C. § 379j(d)(2)(B)

   Pub. L. 108–214, § 2(a)(2)(B), substituted “firms, which show” for “firms. which show” in second sentence

   Source evidence

   Code amendment note
   Subsec. (d)(2)(B). Pub. L. 108–214, § 2(a)(2)(B), substituted “firms, which show” for “firms. which show” in second sentence.

   Enacted provision · exact public law section
   (B) in subsection (d)(2)(B), beginning in the second sentence, by striking “firms. which show” and inserting “firms, which show”;

8. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(a)(2)(C)(i) · 118 Stat. 572

   1. Substituted · 21 U.S.C. § 379j(e)(1)

      Pub. L. 108–214, § 2(a)(2)(C)(i), (d)(2)(B)(ii), substituted “For fiscal year 2004 and each subsequent fiscal year, where” for “Where”

   2. Substituted · 21 U.S.C. § 379j(e)(1)

      Pub. L. 108–214, § 2(a)(2)(C)(i), (d)(2)(B)(ii), substituted “subsection (a)(2)(A)(vii)” for “subsection (a)(1)(A)(vii)”

   Source evidence

   Code amendment note
   Subsec. (e)(1). Pub. L. 108–214, § 2(a)(2)(C)(i), (d)(2)(B)(ii), substituted “For fiscal year 2004 and each subsequent fiscal year, where” for “Where” and “subsection (a)(2)(A)(vii)” for “subsection (a)(1)(A)(vii)”.

   Enacted provision · exact public law section
   (i) in paragraph (1), by striking “Where” and inserting “For fiscal year 2004 and each subsequent fiscal year, where”; and

9. 2004

   Medical Devices Technical Corrections Act

   Pub. L. 108–214 § 2(a)(2)(C)(ii)(I) · 118 Stat. 572

   Substituted · 21 U.S.C. § 379j(e)(2)(B)

   Pub. L. 108–214, § 2(a)(2)(C)(ii)(I), substituted “firms, which show” for “firms. which show”

   Source evidence

   Code amendment note
   Subsec. (e)(2)(B). Pub. L. 108–214, § 2(a)(2)(C)(ii)(I), substituted “firms, which show” for “firms. which show”.

   Enacted provision · exact public law section
   (I) in subparagraph (B), beginning in the second sentence, by striking “firms. which show” and inserting “firms, which show”; and

10. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(a)(2)(C)(ii)(II) · 118 Stat. 572

    1. Substituted · 21 U.S.C. § 379j(e)(2)(C)

       Pub. L. 108–214, § 2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted “For fiscal year 2004 and each subsequent fiscal year, where” for “Where” in cl. (ii)

    2. Substituted · 21 U.S.C. § 379j(e)(2)(C)

       Pub. L. 108–214, § 2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted “subsection (a)(2)(A)(vii)” for “subsection (a)(1)(A)(vii)” in cl. (ii)

    3. Substituted · 21 U.S.C. § 379j(e)(2)(C)

       Pub. L. 108–214, § 2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted “subsection (a)(2)(A)(i)” for “subsection (a)(1)(A)(i)” in cl. (ii)

    Source evidence

    Code amendment note
    Subsec. (e)(2)(C). Pub. L. 108–214, § 2(a)(2)(C)(ii)(II), (d)(2)(B)(iii), substituted “For fiscal year 2004 and each subsequent fiscal year, where” for “Where” in cl. (i), “subsection (a)(2)(A)(vii)” for “subsection (a)(1)(A)(vii)” in cls. (i) and (ii), and “subsection (a)(2)(A)(i)” for “subsection (a)(1)(A)(i)” in cl. (ii).

    Enacted provision · exact public law section
    (II) in subparagraph (C)(i), by striking “Where” and inserting “For fiscal year 2004 and each subsequent fiscal year, where”;

11. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(a)(2)(D) · 118 Stat. 572

    Struck · 21 U.S.C. § 379j(f)

    Pub. L. 108–214, § 2(a)(2)(D), struck out “for filing” after “accepted”

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 108–214, § 2(a)(2)(D), struck out “for filing” after “accepted”.

    Enacted provision · exact public law section
    (D) in subsection (f), by striking “for filing”; and

12. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(a)(2)(E) · 118 Stat. 572

    1. Amended · 21 U.S.C. § 379j(h)(2)(B)

       Pub. L. 108–214, § 2(a)(2)(E), designated existing provisions as cl. (i)

    2. Inserted · 21 U.S.C. § 379j(h)(2)(B)

       Pub. L. 108–214, § 2(a)(2)(E), inserted heading

    3. Redesignated · 21 U.S.C. § 379j(h)(2)(B)

       Pub. L. 108–214, § 2(a)(2)(E), redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i)

    4. Redesignated · 21 U.S.C. § 379j(h)(2)(B)

       Pub. L. 108–214, § 2(a)(2)(E), redesignated former subcls. (I) and (II) of cl. (i) as items (aa) and (bb), respectively, of cl. (i)(II)

    5. Added · 21 U.S.C. § 379j(h)(2)(B)

       Pub. L. 108–214, § 2(a)(2)(E), added cl. (ii)

    Source evidence

    Code amendment note
    Subsec. (h)(2)(B). Pub. L. 108–214, § 2(a)(2)(E), designated existing provisions as cl. (i), inserted heading, redesignated former cls. (i) and (ii) as subcls. (I) and (II), respectively, of cl. (i), redesignated former subcls. (I) and (II) of cl. (i) as items (aa) and (bb), respectively, of cl. (i)(II), and added cl. (ii).

    Enacted provision · exact public law section
    (E) in subsection (h)(2)(B)— (i) in clause (ii), by redesignating subclauses (I) and (II) as items (aa) and (bb), respectively; (ii) by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively; (iii) by striking “The Secretary” and inserting the following: “(i) In general.— The Secretary” ; and (iv) by adding at the end the following: “(ii) More than 5 percent.— To the extent such costs are more than 5 percent below the specified level in subparagraph (A)(ii), fees may not be collected under this section for that fiscal year.” .

13. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(d)(2)(B)(iv) · 118 Stat. 572

    Substituted · 21 U.S.C. § 379j(j)

    Pub. L. 108–214, § 2(d)(2)(B)(iv), substituted “subsection (a)(2)(D)” for “subsection (a)(1)(D)”

    Source evidence

    Code amendment note
    Subsec. (j). Pub. L. 108–214, § 2(d)(2)(B)(iv), substituted “subsection (a)(2)(D)” for “subsection (a)(1)(D)”.

    Enacted provision · exact public law section
    (iv) in subsection (j), by striking “subsection (a)(1)(D),” and inserting “subsection (a)(2)(D),”.

14. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(7) · 119 Stat. 439

    Substituted · 21 U.S.C. § 379j(a)(2)(A)

    Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)”.

    Enacted provision · exact public law section
    (7) by striking “subsection (c)(5)” each place it appears and inserting “subsection (c)(1)”.

15. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(1) · 119 Stat. 439

    1. Inserted · 21 U.S.C. § 379j(b)

       Pub. L. 109–43, § 2(a)(1), inserted “and” after “2004;”

    2. Substituted · 21 U.S.C. § 379j(b)

       Pub. L. 109–43, § 2(a)(1), substituted “2005” for “2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 109–43, § 2(a)(1), inserted “and” after “2004;” and substituted “2005” for “2005; $32,615,000 in fiscal year 2006, and $35,000,000 in fiscal year 2007”.

    Enacted provision · exact public law section
    (1) in subsection (b)— (A) after “2004;”, by inserting “and”; and (B) by striking “2005;” and all that follows through “2007” and inserting “2005”;

16. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(2)(A) · 119 Stat. 439

    Substituted · 21 U.S.C. § 379j(c)

    Pub. L. 109–43, § 2(a)(2)(A), substituted “Annual fee setting” for “Adjustments” in heading

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 109–43, § 2(a)(2)(A), substituted “Annual fee setting” for “Adjustments” in heading.

    Enacted provision · exact public law section
    (A) by striking the heading and inserting “Annual Fee Setting.—”;

17. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(2)(B) · 119 Stat. 439

    1. Redesignated · 21 U.S.C. § 379j(c)(1)

       Pub. L. 109–43, § 2(a)(2)(B)–(D), redesignated par. (5) as (1)

    2. Substituted · 21 U.S.C. § 379j(c)(1)

       Pub. L. 109–43, § 2(a)(2)(B)–(D), substituted “In general” for “Annual fee setting” in text

    3. Substituted · 21 U.S.C. § 379j(c)(1)

       Pub. L. 109–43, § 2(a)(2)(B)–(D), substituted “publish in the Federal Register fees under subsection (a) of this section. The fees” for “establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustment provided under this subsection and subsection (e)(2)(C)(ii) of this section, except that the fees” in text

    4. Substituted · 21 U.S.C. § 379j(c)(1)

       Pub. L. 109–43, § 2(a)(2)(B)–(D), substituted “2006” for “2003” in text

    5. Substituted · 21 U.S.C. § 379j(c)(1)

       Pub. L. 109–43, § 2(a)(2)(B)–(D), substituted “$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.” for “$154,000.” in text

    6. Struck · 21 U.S.C. § 379j(c)(1)

       Pub. L. 109–43, § 2(a)(2)(B)–(D), struck out former par. (1) which required an annual inflation adjustment of the revenues established in subsec. (b)

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 109–43, § 2(a)(2)(B)–(D), redesignated par. (5) as (1), substituted “In general” for “Annual fee setting” in heading, “publish in the Federal Register fees under subsection (a) of this section. The fees” for “establish, for the next fiscal year, and publish in the Federal Register, fees under subsection (a) of this section, based on the revenue amounts established under subsection (b) of this section and the adjustment provided under this subsection and subsection (e)(2)(C)(ii) of this section, except that the fees”, “2006” for “2003”, and “$259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.” for “$154,000.” in text, and struck out former par. (1) which required an annual inflation adjustment of the revenues established in subsec. (b).

    Enacted provision · exact public law section
    (B) by striking paragraphs (1), (2), (3), and (4);

18. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(2)(B) · 119 Stat. 439

    1. Redesignated · 21 U.S.C. § 379j(c)(2)

       Pub. L. 109–43, § 2(a)(2)(B), (C), redesignated par. (6) as (2)

    2. Struck · 21 U.S.C. § 379j(c)(2)

       Pub. L. 109–43, § 2(a)(2)(B), (C), struck out former par. (2) which required an annual adjustment of the fee revenues established in subsec. (b) to reflect changes in the workload of the Secretary for the process for the review of device applications

    Source evidence

    Code amendment note
    Subsec. (c)(2). Pub. L. 109–43, § 2(a)(2)(B), (C), redesignated par. (6) as (2) and struck out former par. (2) which required an annual adjustment of the fee revenues established in subsec. (b) to reflect changes in the workload of the Secretary for the process for the review of device applications.

    Enacted provision · exact public law section
    (B) by striking paragraphs (1), (2), (3), and (4);

19. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(2)(B) · 119 Stat. 439

    1. Added · 21 U.S.C. § 379j(c)(3)

       Pub. L. 109–43, § 2(a)(2)(B), (E), added par. (3)

    2. Struck · 21 U.S.C. § 379j(c)(3)

       Pub. L. 109–43, § 2(a)(2)(B), (E), struck out former par. (3) which required an annual compensating adjustment of the fee revenues established in subsec. (b)

    Source evidence

    Code amendment note
    Subsec. (c)(3). Pub. L. 109–43, § 2(a)(2)(B), (E), added par. (3) and struck out former par. (3) which required an annual compensating adjustment of the fee revenues established in subsec. (b).

    Enacted provision · exact public law section
    (B) by striking paragraphs (1), (2), (3), and (4);

20. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(2)(B) · 119 Stat. 439

    Struck · 21 U.S.C. § 379j(c)(4)

    Pub. L. 109–43, § 2(a)(2)(B), struck out par. (4) which provided for a fiscal year 2007 adjustment of the fee revenues established in subsec. (b) to provide for operating reserves of carryover user fees

    Source evidence

    Code amendment note
    Subsec. (c)(4). Pub. L. 109–43, § 2(a)(2)(B), struck out par. (4) which provided for a fiscal year 2007 adjustment of the fee revenues established in subsec. (b) to provide for operating reserves of carryover user fees.

    Enacted provision · exact public law section
    (B) by striking paragraphs (1), (2), (3), and (4);

21. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(2)(C) · 119 Stat. 439

    Redesignated · 21 U.S.C. § 379j(c)(5); 21 U.S.C. § 379j(c)(6)

    Pub. L. 109–43, § 2(a)(2)(C), redesignated pars. (5) and (6) as (1) and (2), respectively

    Source evidence

    Code amendment note
    Subsec. (c)(5), (6). Pub. L. 109–43, § 2(a)(2)(C), redesignated pars. (5) and (6) as (1) and (2), respectively.

    Enacted provision · exact public law section
    (C) by redesignating paragraphs (5) and (6) as paragraphs (1) and (2), respectively;

22. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(3)(A) · 119 Stat. 439

    Inserted · 21 U.S.C. § 379j(d)(1)

    Pub. L. 109–43, § 2(a)(3)(A), inserted after first sentence “For the purposes of this paragraph, the term ‘small business’ means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms.”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 109–43, § 2(a)(3)(A), inserted after first sentence “For the purposes of this paragraph, the term ‘small business’ means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms.”

    Enacted provision · exact public law section
    (A) in paragraph (1), by inserting after the first sentence the following: “For the purposes of this paragraph, the term ‘small business’ means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates, partners, and parent firms.”; and

23. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(3)(B) · 119 Stat. 439

    1. Struck · 21 U.S.C. § 379j(d)(2)(A)

       Pub. L. 109–43, § 2(a)(3)(B), struck out cl. (i) designation and heading before “For purposes”

    2. Substituted · 21 U.S.C. § 379j(d)(2)(A)

       Pub. L. 109–43, § 2(a)(3)(B), substituted “paragraph,” for “subsection,”

    3. Substituted · 21 U.S.C. § 379j(d)(2)(A)

       Pub. L. 109–43, § 2(a)(3)(B), substituted “$100,000,000” for “$30,000,000”

    4. Struck · 21 U.S.C. § 379j(d)(2)(A)

       Pub. L. 109–43, § 2(a)(3)(B), struck out heading and text of clause (ii). Text read as follows: “The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold.”

    Source evidence

    Code amendment note
    Subsec. (d)(2)(A). Pub. L. 109–43, § 2(a)(3)(B), struck out cl. (i) designation and heading before “For purposes”, substituted “paragraph,” for “subsection,” and “$100,000,000” for “$30,000,000”, and struck out heading and text of clause (ii). Text read as follows: “The Secretary may adjust the $30,000,000 threshold established in clause (i) if the Secretary has evidence from actual experience that this threshold results in a reduction in revenues from premarket applications, premarket reports, and supplements that is 16 percent or more than would occur without small business exemptions and lower fee rates. To adjust this threshold, the Secretary shall publish a notice in the Federal Register setting out the rationale for the adjustment, and the new threshold.”

    Enacted provision · exact public law section
    (B) in paragraph (2)(A), by— (i) striking “(i) In general.—”; (ii) striking “subsection,” and inserting “paragraph,”; (iii) striking “$30,000,000” and inserting “$100,000,000”; and (iv) striking clause (ii);

24. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(7) · 119 Stat. 439

    Substituted · 21 U.S.C. § 379j(d)(2)(C)

    Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)”

    Source evidence

    Code amendment note
    Subsec. (d)(2)(C). Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)”.

    Enacted provision · exact public law section
    (7) by striking “subsection (c)(5)” each place it appears and inserting “subsection (c)(1)”.

25. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(4) · 119 Stat. 439

    Substituted · 21 U.S.C. § 379j(e)(2)(A)

    Pub. L. 109–43, § 2(a)(4), substituted “$100,000,000” for “$30,000,000”

    Source evidence

    Code amendment note
    Subsec. (e)(2)(A). Pub. L. 109–43, § 2(a)(4), substituted “$100,000,000” for “$30,000,000”.

    Enacted provision · exact public law section
    (4) in subsection (e)(2)(A), by striking “$30,000,000” and inserting “$100,000,000”;

26. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(7) · 119 Stat. 439

    Substituted · 21 U.S.C. § 379j(e)(2)(C)

    Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)” in cls. (i) and (ii)

    Source evidence

    Code amendment note
    Subsec. (e)(2)(C). Pub. L. 109–43, § 2(a)(7), substituted “subsection (c)(1)” for “subsection (c)(5)” in cls. (i) and (ii).

    Enacted provision · exact public law section
    (7) by striking “subsection (c)(5)” each place it appears and inserting “subsection (c)(1)”.

27. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(5)(A)(i) · 119 Stat. 439

    1. Added · 21 U.S.C. § 379j(g)(1)(B)(i)

       Pub. L. 109–43, § 2(a)(5)(A)(i), added cl. (i)

    2. Struck · 21 U.S.C. § 379j(g)(1)(B)(i)

       Pub. L. 109–43, § 2(a)(5)(A)(i), struck out former cl. (i) which read as follows: “For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of—

    Source evidence

    Code amendment note
    Subsec. (g)(1)(B)(i). Pub. L. 109–43, § 2(a)(5)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows: “For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is equal to or greater than the sum of—

    “(I) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2003; “(II) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2004; and “(III) $205,720,000 multiplied by the adjustment factor applicable to fiscal year 2005.”

    Enacted provision · exact public law section
    (i) by striking clause (i) and inserting the following: “(i) For fiscal year 2005, the Secretary is expected to meet all of the performance goals identified for the fiscal year if the amount so appropriated for such fiscal year, excluding the amount of fees appropriated for such fiscal year, is equal to or greater than $205,720,000 multiplied by the adjustment factor applicable to the fiscal year.” ; and

28. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(5)(A)(ii) · 119 Stat. 439

    1. Added · 21 U.S.C. § 379j(g)(1)(B)(ii)

       Pub. L. 109–43, § 2(a)(5)(A)(ii), added introductory provisions

    2. Struck · 21 U.S.C. § 379j(g)(1)(B)(ii)

       Pub. L. 109–43, § 2(a)(5)(A)(ii), struck out former introductory provisions which read as follows: “For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies:”

    Source evidence

    Code amendment note
    Subsec. (g)(1)(B)(ii). Pub. L. 109–43, § 2(a)(5)(A)(ii), added introductory provisions and struck out former introductory provisions which read as follows: “For fiscal year 2005, if the total of the amounts so appropriated for fiscal years 2003 through 2005, excluding the amount of fees appropriated for such fiscal years, is less than the sum that applies under clause (i) for fiscal year 2005, the following applies:”.

    Enacted provision · exact public law section
    (ii) in clause (ii), by striking the matter preceding subclause (I) and inserting the following: “(ii) For fiscal year 2005, if the amount so appropriated for such fiscal year, excluding the amount of fees appropriated for such fiscal year, is more than 1 percent less than the amount that applies under clause (i), the following applies:” ;

29. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(5)(B)(i) · 119 Stat. 439

    1. Substituted · 21 U.S.C. § 379j(g)(1)(C)

       Pub. L. 109–43, § 2(a)(5)(B)(i), substituted “2005 and” for “2003 through”

    2. Inserted · 21 U.S.C. § 379j(g)(1)(C)

       Pub. L. 109–43, § 2(a)(5)(B)(i), inserted “more than 1 percent” after “years, is”

    Source evidence

    Code amendment note
    Subsec. (g)(1)(C). Pub. L. 109–43, § 2(a)(5)(B)(i), substituted “2005 and” for “2003 through” and inserted “more than 1 percent” after “years, is”.

    Enacted provision · exact public law section
    (i) in the matter preceding clause (i), by— (I) striking “2003 through” and inserting “2005 and”; and (II) inserting “more than 1 percent” after “years, is”; and

30. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(5)(B)(ii) · 119 Stat. 439

    Substituted · 21 U.S.C. § 379j(g)(1)(C)(ii)

    Pub. L. 109–43, § 2(a)(5)(B)(ii), substituted “amount that applies” for “sum that applies”

    Source evidence

    Code amendment note
    Subsec. (g)(1)(C)(ii). Pub. L. 109–43, § 2(a)(5)(B)(ii), substituted “amount that applies” for “sum that applies”.

    Enacted provision · exact public law section
    (ii) in clause (ii), by striking “sum” and inserting “amount”; and

31. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(5)(C) · 119 Stat. 439

    Inserted · 21 U.S.C. § 379j(g)(1)(D)(i)

    Pub. L. 109–43, § 2(a)(5)(C), inserted “more than 1 percent” after “year, is”

    Source evidence

    Code amendment note
    Subsec. (g)(1)(D)(i). Pub. L. 109–43, § 2(a)(5)(C), inserted “more than 1 percent” after “year, is”.

    Enacted provision · exact public law section
    (C) in subparagraph (D)(i), by inserting “more than 1 percent” after “year, is”;

32. 2005

    Medical Device User Fee Stabilization Act of 2005

    Pub. L. 109–43 § 2(a)(6) · 119 Stat. 439

    1. Added · 21 U.S.C. § 379j(h)(3)(D); 21 U.S.C. § 379j(h)(3)(E)

       Pub. L. 109–43, § 2(a)(6), added subpar. (D)

    2. Struck · 21 U.S.C. § 379j(h)(3)(D); 21 U.S.C. § 379j(h)(3)(E)

       Pub. L. 109–43, § 2(a)(6), struck out former subpars. (D) and (E) which read as follows:

    Source evidence

    Code amendment note
    Subsec. (h)(3)(D), (E). Pub. L. 109–43, § 2(a)(6), added subpar. (D) and struck out former subpars. (D) and (E) which read as follows:

    “(D) $32,615,000 for fiscal year 2006; and “(E) $35,000,000 for fiscal year 2007,”.

    Enacted provision · exact public law section
    (6) in subsection (h)(3)— (A) in subparagraph (C), by striking the semicolon and inserting “; and”; and (B) by striking subparagraphs (D) and (E) and inserting the following: “(D) such sums as may be necessary for each of fiscal years 2006 and 2007.” ; and

33. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(1)(A) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379j(a)(1)

    Pub. L. 110–85, § 212(a)(1)(A), substituted “Beginning in fiscal year 2008” for “Beginning on October 26, 2002”

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 110–85, § 212(a)(1)(A), substituted “Beginning in fiscal year 2008” for “Beginning on October 26, 2002”.

    Enacted provision · exact public law section
    (A) in paragraph (1), by striking “Beginning on the date of the enactment of the Medical Device User Fee and Modernization Act of 2002” and inserting “Beginning in fiscal year 2008”; and

34. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(1)(B) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(a)(2)

    Pub. L. 110–85, § 212(a)(1)(B), amended heading generally. Prior to amendment, heading read as follows: “Premarket application, premarket report, supplement, and submission fee”

    Source evidence

    Code amendment note
    Subsec. (a)(2). Pub. L. 110–85, § 212(a)(1)(B), amended heading generally. Prior to amendment, heading read as follows: “Premarket application, premarket report, supplement, and submission fee”.

    Enacted provision · exact public law section
    (B) by amending the designation and heading of paragraph (2) to read as follows: “(2) Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class iii device.— ” .

35. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(2)(A) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379j(a)(2)(A)(iii)

    Pub. L. 110–85, § 212(a)(2)(A), substituted “a fee equal to 75 percent of the fee that applies” for “a fee equal to the fee that applies”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(iii). Pub. L. 110–85, § 212(a)(2)(A), substituted “a fee equal to 75 percent of the fee that applies” for “a fee equal to the fee that applies”.

    Enacted provision · exact public law section
    (A) in clause (iii), by striking “a fee equal to the fee that applies” and inserting “a fee equal to 75 percent of the fee that applies”;

36. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(2)(B) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379j(a)(2)(A)(iv)

    Pub. L. 110–85, § 212(a)(2)(B), substituted “15 percent” for “21.5 percent”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(iv). Pub. L. 110–85, § 212(a)(2)(B), substituted “15 percent” for “21.5 percent”.

    Enacted provision · exact public law section
    (B) in clause (iv), by striking “21.5 percent” and inserting “15 percent”;

37. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(2)(C) · 121 Stat. 823

    Substituted · 21 U.S.C. § 379j(a)(2)(A)(v)

    Pub. L. 110–85, § 212(a)(2)(C), substituted “7 percent” for “7.2 percent”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(v). Pub. L. 110–85, § 212(a)(2)(C), substituted “7 percent” for “7.2 percent”.

    Enacted provision · exact public law section
    (C) in clause (v), by striking “7.2 percent” and inserting “7 percent”;

38. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(2)(D) · 121 Stat. 823

    1. Added · 21 U.S.C. § 379j(a)(2)(A)(vi); 21 U.S.C. § 379j(a)(2)(A)(vii)

       Pub. L. 110–85, § 212(a)(2)(D), (E), added cl. (vi)

    2. Redesignated · 21 U.S.C. § 379j(a)(2)(A)(vi); 21 U.S.C. § 379j(a)(2)(A)(vii)

       Pub. L. 110–85, § 212(a)(2)(D), (E), redesignated former cl. (vi) as (vii). Former cl. (vii) redesignated (viii)

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(vi), (vii). Pub. L. 110–85, § 212(a)(2)(D), (E), added cl. (vi) and redesignated former cl. (vi) as (vii). Former cl. (vii) redesignated (viii).

    Enacted provision · exact public law section
    (D) by redesignating clauses (vi) and (vii) as clauses (vii) and (viii), respectively;

39. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(2)(D) · 121 Stat. 823

    1. Redesignated · 21 U.S.C. § 379j(a)(2)(A)(viii)

       Pub. L. 110–85, § 212(a)(2)(D), (F), redesignated cl. (vii) as (viii)

    2. Substituted · 21 U.S.C. § 379j(a)(2)(A)(viii)

       Pub. L. 110–85, § 212(a)(2)(D), (F), substituted “1.84 percent” for “1.42 percent”

    3. Struck · 21 U.S.C. § 379j(a)(2)(A)(viii)

       Pub. L. 110–85, § 212(a)(2)(D), (F), struck out “, subject to any adjustment under subsection (e)(2)(C)(ii) of this section” before period at end

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(viii). Pub. L. 110–85, § 212(a)(2)(D), (F), redesignated cl. (vii) as (viii), substituted “1.84 percent” for “1.42 percent”, and struck out “, subject to any adjustment under subsection (e)(2)(C)(ii) of this section” before period at end.

    Enacted provision · exact public law section
    (D) by redesignating clauses (vi) and (vii) as clauses (vii) and (viii), respectively;

40. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(2)(G) · 121 Stat. 823

    Added · 21 U.S.C. § 379j(a)(2)(A)(ix); 21 U.S.C. § 379j(a)(2)(A)(x)

    Pub. L. 110–85, § 212(a)(2)(G), added cls. (ix) and (x)

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(ix), (x). Pub. L. 110–85, § 212(a)(2)(G), added cls. (ix) and (x).

    Enacted provision · exact public law section
    (G) by inserting after such clause (viii) the following: “(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i). “(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).” .

41. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(3) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(a)(2)(C)

    Pub. L. 110–85, § 212(a)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: “The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 360e(c)(3) of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003.”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(C). Pub. L. 110–85, § 212(a)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: “The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, or premarket notification submission except that invoices for applications submitted between October 1, 2002, and October 26, 2002, shall be payable on October 30, 2002. Applicants submitting portions of applications pursuant to section 360e(c)(3) of this title shall pay such fees upon submission of the first portion of such applications. The fees credited to fiscal year 2003 under this section shall include all fees payable from October 1, 2002, through September 30, 2003.”

    Enacted provision · exact public law section
    (3) Payment.— Section 738(a)(2)(C) (21 U.S.C. 379j(a)(2)(C)) is amended to read as follows: “(C) Payment.— The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device. Applicants submitting portions of applications pursuant to section 515(c)(4) shall pay such fees upon submission of the first portion of such applications.” .

42. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(4)(A) · 121 Stat. 823

    Struck · 21 U.S.C. § 379j(a)(2)(D)(iii)

    Pub. L. 110–85, § 212(a)(4)(A), struck out at end “The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(D)(iii). Pub. L. 110–85, § 212(a)(4)(A), struck out at end “The Secretary shall have sole discretion to refund a fee or portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.”

    Enacted provision · exact public law section
    (A) in clause (iii), by striking the last two sentences; and

43. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(4)(B) · 121 Stat. 823

    Added · 21 U.S.C. § 379j(a)(2)(D)(iv)(vi)

    Pub. L. 110–85, § 212(a)(4)(B), added cls. (iv) to (vi)

    Source evidence

    Code amendment note
    Subsec. (a)(2)(D)(iv) to (vi). Pub. L. 110–85, § 212(a)(4)(B), added cls. (iv) to (vi).

    Enacted provision · exact public law section
    (B) by adding after clause (iii) the following: “(iv) Modular applications withdrawn before first action.— The Secretary shall refund 75 percent of the application fee paid for an application submitted under section 515(c)(4) that is withdrawn before a second portion is submitted and before a first action on the first portion. “(v) Later withdrawn modular applications.— If an application submitted under section 515(c)(4) is withdrawn after a second or subsequent portion is submitted but before any first action, the Secretary may return a portion of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of the portions submitted. “(vi) Sole discretion to refund.— The Secretary shall have sole discretion to refund a fee or portion of the fee under clause (iii) or (v). A determination by the Secretary concerning a refund under clause (iii) or (v) shall not be reviewable.” .

44. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(a)(5) · 121 Stat. 823

    Added · 21 U.S.C. § 379j(a)(3)

    Pub. L. 110–85, § 212(a)(5), added par. (3)

    Source evidence

    Code amendment note
    Subsec. (a)(3). Pub. L. 110–85, § 212(a)(5), added par. (3).

    Enacted provision · exact public law section
    (5) Annual establishment registration fee.— Section 738(a) (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) the following: “(3) Annual establishment registration fee.— “(A) In general.— Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 510 beginning with its registration for fiscal year 2008. “(B) Exception.— No fee shall be required under subparagraph (A) for an establishment operated by a State or Federal governmental entity or an Indian tribe (as defined in the Indian Self Determination and Educational Assistance Act), unless a device manufactured by the establishment is to be distributed commercially. “(C) Payment.— The fee required under subparagraph (A) shall be due once each fiscal year, upon the initial registration of the establishment or upon the annual registration under section 510.” .

45. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(b) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(b)

    Pub. L. 110–85, § 212(b), amended subsec. (b) generally. Prior to amendment, text read as follows: “Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications.”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 110–85, § 212(b), amended subsec. (b) generally. Prior to amendment, text read as follows: “Except as provided in subsections (c), (d), (e), (g), and (h) of this section, the fees under subsection (a) of this section shall be established to generate the following revenue amounts: $25,125,000 in fiscal year 2003; $27,255,000 in fiscal year 2004; and $29,785,000 in fiscal year 2005. If legislation is enacted after October 26, 2002, requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts under this subsection shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of device applications.”

    Enacted provision · exact public law section
    (b) Fee Amounts.— Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows: “(b) Fee Amounts.— Except as provided in subsections (c), (d), (e), and (h) the fees under subsection (a) shall be based on the following fee amounts: Fee TypeFiscal Year 2008Fiscal Year 2009Fiscal Year 2010Fiscal Year 2011Fiscal Year 2012 Premarket Application$185,000$200,725$217,787$236,298$256,384   Establishment Registration$1,706$1,851$2,008$2,179$2,364.”.

46. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(c)(1)(A) · 121 Stat. 823

    Changed · 21 U.S.C. § 379j(c)

    Pub. L. 110–85, § 212(c)(1)(A), made technical amendment to heading

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 110–85, § 212(c)(1)(A), made technical amendment to heading.

    Enacted provision · exact public law section
    (A) in the subsection heading, by striking “Annual Fee Setting” and inserting “Annual Fee Setting”; and

47. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(c)(1)(B) · 121 Stat. 823

    Struck · 21 U.S.C. § 379j(c)(1)

    Pub. L. 110–85, § 212(c)(1)(B), struck out at end “The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.”

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 110–85, § 212(c)(1)(B), struck out at end “The fees established for fiscal year 2006 shall be based on a premarket application fee of $259,600, and the fees established for fiscal year 2007 shall be based on a premarket application fee of $281,600.”

    Enacted provision · exact public law section
    (B) in paragraph (1), by striking the last sentence.

48. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(c)(2)(A) · 121 Stat. 823

    1. Added · 21 U.S.C. § 379j(c)(2); 21 U.S.C. § 379j(c)(3)

       Pub. L. 110–85, § 212(c)(2)(A), (B), added par. (2)

    2. Redesignated · 21 U.S.C. § 379j(c)(2); 21 U.S.C. § 379j(c)(3)

       Pub. L. 110–85, § 212(c)(2)(A), (B), redesignated former par. (2) as (3). Former par. (3) redesignated (4)

    Source evidence

    Code amendment note
    Subsec. (c)(2), (3). Pub. L. 110–85, § 212(c)(2)(A), (B), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4).

    Enacted provision · exact public law section
    (A) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

49. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(c)(2)(A) · 121 Stat. 823

    1. Redesignated · 21 U.S.C. § 379j(c)(4)

       Pub. L. 110–85, § 212(c)(2)(A), (C), redesignated par. (3) as (4)

    2. Substituted · 21 U.S.C. § 379j(c)(4)

       Pub. L. 110–85, § 212(c)(2)(A), (C), substituted in subpar. (A) “The Secretary” for “For fiscal years 2006 and 2007, the Secretary”

    3. Substituted · 21 U.S.C. § 379j(c)(4)

       Pub. L. 110–85, § 212(c)(2)(A), (C), substituted in subpar. (A) “for the first month of the next fiscal year” for “for the first month of fiscal year 2008”

    Source evidence

    Code amendment note
    Subsec. (c)(4). Pub. L. 110–85, § 212(c)(2)(A), (C), redesignated par. (3) as (4) and substituted in subpar. (A) “The Secretary” for “For fiscal years 2006 and 2007, the Secretary” and “for the first month of the next fiscal year” for “for the first month of fiscal year 2008”.

    Enacted provision · exact public law section
    (A) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively;

50. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(d)(1) · 121 Stat. 823

    1. Struck · 21 U.S.C. § 379j(d)(1)

       Pub. L. 110–85, § 212(d)(1), struck out “, partners, and parent firms” after “affiliates”

    2. Substituted · 21 U.S.C. § 379j(d)(1)

       Pub. L. 110–85, § 212(d)(1), substituted “clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)” for “clauses (i) through (vi) of subsection (a)(2)(A) of this section”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 110–85, § 212(d)(1), struck out “, partners, and parent firms” after “affiliates” and substituted “clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)” for “clauses (i) through (vi) of subsection (a)(2)(A) of this section”.

    Enacted provision · exact public law section
    (1) In general.— Section 738(d)(1) (21 U.S.C. 379j(d)(1)) is amended— (A) by striking “, partners, and parent firms”; and (B) by striking “clauses (i) through (vi) of subsection (a)(2)(A)” and inserting “clauses (i) through (v) and clauses (vii), (ix), and (x) of subsection (a)(2)(A)”.

51. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(d)(2)(A) · 121 Stat. 823

    Struck · 21 U.S.C. § 379j(d)(2)(A)

    Pub. L. 110–85, § 212(d)(2)(A), struck out “, partners, and parent firms” before period at end

    Source evidence

    Code amendment note
    Subsec. (d)(2)(A). Pub. L. 110–85, § 212(d)(2)(A), struck out “, partners, and parent firms” before period at end.

    Enacted provision · exact public law section
    (A) Definition.— Section 738(d)(2)(A) (21 U.S.C. 379j(d)(2)(A)) is amended by striking “, partners, and parent firms”.

52. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(d)(2)(B)(i) · 121 Stat. 823

    1. Amended · 21 U.S.C. § 379j(d)(2)(B)

       Pub. L. 110–85, § 212(d)(2)(B)(i), (ii), designated first sentence as cl. (i) and second to fourth sentences as cl. (ii)

    2. Inserted · 21 U.S.C. § 379j(d)(2)(B)

       Pub. L. 110–85, § 212(d)(2)(B)(i), (ii), inserted cl. headings

    Source evidence

    Code amendment note
    Subsec. (d)(2)(B). Pub. L. 110–85, § 212(d)(2)(B)(i), (ii), designated first sentence as cl. (i) and second to fourth sentences as cl. (ii) and inserted cl. headings.

    Enacted provision · exact public law section
    (i) by striking “(B) Evidence of qualification.—An applicant” and inserting the following: “(B) Evidence of qualification.— “(i) In general.— An applicant” ;

53. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(d)(2)(B)(iii) · 121 Stat. 823

    1. Struck · 21 U.S.C. § 379j(d)(2)(B)(ii)

       Pub. L. 110–85, § 212(d)(2)(B)(iii), (iv), struck out “, partners, and parent firms” after “its affiliates” and after “such affiliates”

    2. Substituted · 21 U.S.C. § 379j(d)(2)(B)(ii)

       Pub. L. 110–85, § 212(d)(2)(B)(iii), (iv), substituted “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.” for “If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.”

    Source evidence

    Code amendment note
    Subsec. (d)(2)(B)(ii). Pub. L. 110–85, § 212(d)(2)(B)(iii), (iv), struck out “, partners, and parent firms” after “its affiliates” and after “such affiliates” and substituted “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.” for “If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.”

    Enacted provision · exact public law section
    (iii) by striking “, partners, and parent firms” each place it appears;

54. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(d)(2)(B)(v) · 121 Stat. 823

    Added · 21 U.S.C. § 379j(d)(2)(B)(iii)

    Pub. L. 110–85, § 212(d)(2)(B)(v), added cl. (iii)

    Source evidence

    Code amendment note
    Subsec. (d)(2)(B)(iii). Pub. L. 110–85, § 212(d)(2)(B)(v), added cl. (iii).

    Enacted provision · exact public law section
    (v) by adding at the end the following: “(iii) Firms not submitting tax returns to the united states internal revenue service.— In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.” .

55. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(d)(3) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(d)(2)(C)

    Pub. L. 110–85, § 212(d)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: “Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement.”

    Source evidence

    Code amendment note
    Subsec. (d)(2)(C). Pub. L. 110–85, § 212(d)(3), amended subpar. (C) generally. Prior to amendment, text read as follows: “Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) of this section may be paid at a reduced rate of 38 percent of the fee established under such subsection for a premarket application, a premarket report, or a supplement.”

    Enacted provision · exact public law section
    (3) Reduced fees.— Section 738(d)(2)(C) (21 U.S.C. 379j(d)(2)(C)) is amended to read as follows: “(C) Reduced fees.— Where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fees established under subsection (c)(1) may be paid at a reduced rate of— “(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, or periodic reporting concerning a class III device; and “(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.” .

56. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(e)(1) · 121 Stat. 823

    1. Substituted · 21 U.S.C. § 379j(e)(1)

       Pub. L. 110–85, § 212(e)(1), substituted “2008” for “2004”

    2. Substituted · 21 U.S.C. § 379j(e)(1)

       Pub. L. 110–85, § 212(e)(1), substituted “(a)(2)(A)(viii)” for “(a)(2)(A)(vii)”

    Source evidence

    Code amendment note
    Subsec. (e)(1). Pub. L. 110–85, § 212(e)(1), substituted “2008” for “2004” and “(a)(2)(A)(viii)” for “(a)(2)(A)(vii)”.

    Enacted provision · exact public law section
    (1) In general.— Section 738(e)(1) (21 U.S.C. 379j(e)(1)) is amended— (A) by striking “2004” and inserting “2008”; and (B) by striking “(a)(2)(A)(vii)” and inserting “(a)(2)(A)(viii)”.

57. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(e)(2)(A) · 121 Stat. 823

    Struck · 21 U.S.C. § 379j(e)(2)(A)

    Pub. L. 110–85, § 212(e)(2)(A), struck out “, partners, and parent firms” before period at end

    Source evidence

    Code amendment note
    Subsec. (e)(2)(A). Pub. L. 110–85, § 212(e)(2)(A), struck out “, partners, and parent firms” before period at end.

    Enacted provision · exact public law section
    (A) Definition.— Section 738(e)(2)(A) (21 U.S.C. 379j(e)(2)(A)) is amended by striking “, partners, and parent firms”.

58. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(e)(2)(B)(i) · 121 Stat. 823

    1. Inserted · 21 U.S.C. § 379j(e)(2)(B)

       Pub. L. 110–85, § 212(e)(2)(B)(i), (ii), inserted cl. headings

    2. Amended · 21 U.S.C. § 379j(e)(2)(B)

       Pub. L. 110–85, § 212(e)(2)(B)(i), (ii), designated first sentence as cl. (i) and second to fourth sentences as cl. (ii)

    Source evidence

    Code amendment note
    Subsec. (e)(2)(B). Pub. L. 110–85, § 212(e)(2)(B)(i), (ii), inserted cl. headings and designated first sentence as cl. (i) and second to fourth sentences as cl. (ii).

    Enacted provision · exact public law section
    (i) by striking “(B) Evidence of qualification.—An applicant” and inserting the following: “(B) Evidence of qualification.— “(i) In general.— An applicant” ;

59. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(e)(2)(B)(iii) · 121 Stat. 823

    1. Struck · 21 U.S.C. § 379j(e)(2)(B)(ii)

       Pub. L. 110–85, § 212(e)(2)(B)(iii), (iv), struck out “, partners, and parent firms” after “its affiliates” and after “such affiliates”

    2. Substituted · 21 U.S.C. § 379j(e)(2)(B)(ii)

       Pub. L. 110–85, § 212(e)(2)(B)(iii), (iv), substituted “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.” for “If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.”

    Source evidence

    Code amendment note
    Subsec. (e)(2)(B)(ii). Pub. L. 110–85, § 212(e)(2)(B)(iii), (iv), struck out “, partners, and parent firms” after “its affiliates” and after “such affiliates” and substituted “If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.” for “If no tax forms are submitted for affiliates, partners, or parent firms, the applicant shall certify that the applicant has no affiliates, partners, or parent firms, respectively.”

    Enacted provision · exact public law section
    (iii) by striking “, partners, and parent firms” each place it appears;

60. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(e)(2)(B)(v) · 121 Stat. 823

    Added · 21 U.S.C. § 379j(e)(2)(B)(iii)

    Pub. L. 110–85, § 212(e)(2)(B)(v), added cl. (iii)

    Source evidence

    Code amendment note
    Subsec. (e)(2)(B)(iii). Pub. L. 110–85, § 212(e)(2)(B)(v), added cl. (iii).

    Enacted provision · exact public law section
    (v) by adding at the end the following: “(iii) Firms not submitting tax returns to the united states internal revenue service.— In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.” .

61. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(e)(3) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(e)(2)(C)

    Pub. L. 110–85, § 212(e)(3), amended subpar. (C) generally. Prior to amendment, subpar. (C) contained provisions, for fiscal year 2004 and each subsequent fiscal year, authorizing in cl. (i) a reduced fee for a premarket notification submission, and directing in cl. (ii) the Secretary how to determine an adjustment per fee revenue amount

    Source evidence

    Code amendment note
    Subsec. (e)(2)(C). Pub. L. 110–85, § 212(e)(3), amended subpar. (C) generally. Prior to amendment, subpar. (C) contained provisions, for fiscal year 2004 and each subsequent fiscal year, authorizing in cl. (i) a reduced fee for a premarket notification submission, and directing in cl. (ii) the Secretary how to determine an adjustment per fee revenue amount.

    Enacted provision · exact public law section
    (3) Reduced fees.— Section 738(e)(2)(C) (21 U.S.C. 379j(e)(2)(C)) is amended to read as follows: “(C) Reduced fees.— For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 50 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).” .

62. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(f) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(f)

    Pub. L. 110–85, § 212(f), amended subsec. (f) generally. Prior to amendment, text read as follows: “A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid.”

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 110–85, § 212(f), amended subsec. (f) generally. Prior to amendment, text read as follows: “A premarket application, premarket report, supplement, or premarket notification submission submitted by a person subject to fees under subsection (a) of this section shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid.”

    Enacted provision · exact public law section
    (f) Effect of Failure To Pay Fees.— Section 738(f) (21 U.S.C. 379j(f)) is amended to read as follows: “(f) Effect of Failure To Pay Fees.— “(1) No acceptance of submissions.— A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, or periodic reporting concerning a class III device submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all fees owed by such person have been paid. “(2) No registration.— Registration information submitted under section 510 by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 510.” .

63. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(g)(1) · 121 Stat. 823

    1. Added · 21 U.S.C. § 379j(g)(1)

       Pub. L. 110–85, § 212(g)(1), added par. (1)

    2. Struck · 21 U.S.C. § 379j(g)(1)

       Pub. L. 110–85, § 212(g)(1), struck out former par. (1). Prior to amendment, par. (1) related to performance goals for fiscal years 2003 through 2005, with respect to the amount appropriated under the salaries and expenses account of the Food and Drug Administration, for devices and radiological products, and termination of the program after fiscal year 2005

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 110–85, § 212(g)(1), added par. (1) and struck out former par. (1). Prior to amendment, par. (1) related to performance goals for fiscal years 2003 through 2005, with respect to the amount appropriated under the salaries and expenses account of the Food and Drug Administration, for devices and radiological products, and termination of the program after fiscal year 2005.

    Enacted provision · exact public law section
    (1) by striking paragraph (1) and inserting the following: “(1) Performance goals; termination of program.— With respect to the amount that, under the salaries and expenses account of the Food and Drug Administration, is appropriated for a fiscal year for devices and radiological products, fees may not be assessed under subsection (a) for the fiscal year, and the Secretary is not expected to meet any performance goals identified for the fiscal year, if— “(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $205,720,000 multiplied by the adjustment factor applicable to such fiscal year; or “(B) fees were not assessed under subsection (a) for the previous fiscal year.” ; and

64. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(g)(2) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(g)(2)

    Pub. L. 110–85, § 212(g)(2), amended par. (2) generally. Prior to amendment, text read as follows: “If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid.”

    Source evidence

    Code amendment note
    Subsec. (g)(2). Pub. L. 110–85, § 212(g)(2), amended par. (2) generally. Prior to amendment, text read as follows: “If the Secretary does not assess fees under subsection (a) of this section during any portion of a fiscal year because of subparagraph (C) or (D) of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, and premarket notification submissions, and at any time in such fiscal year, notwithstanding the provisions of subsection (a) of this section relating to the date fees are to be paid.”

    Enacted provision · exact public law section
    (2) by amending paragraph (2) to read as follows: “(2) Authority.— If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.” .

65. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(h)(1) · 121 Stat. 823

    1. Amended · 21 U.S.C. § 379j(h)(3)

       Pub. L. 110–85, § 212(h)(1), amended par. (3) generally

    2. Substituted · 21 U.S.C. § 379j(h)(3)

       Pub. L. 110–85, § 212(h)(1), substituting provisions authorizing appropriations for fiscal years 2008 to 2012 for provisions authorizing appropriations for fiscal years 2003 to 2007

    Source evidence

    Code amendment note
    Subsec. (h)(3). Pub. L. 110–85, § 212(h)(1), amended par. (3) generally, substituting provisions authorizing appropriations for fiscal years 2008 to 2012 for provisions authorizing appropriations for fiscal years 2003 to 2007.

    Enacted provision · exact public law section
    (1) Authorization of appropriations.— Section 738(h)(3) (21 U.S.C. 379j(h)(3)) is amended to read as follows: “(3) Authorizations of appropriations.— There are authorized to be appropriated for fees under this section— “(A) $48,431,000 for fiscal year 2008; “(B) $52,547,000 for fiscal year 2009; “(C) $57,014,000 for fiscal year 2010; “(D) $61,860,000 for fiscal year 2011; and “(E) $67,118,000 for fiscal year 2012.” .

66. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 212(h)(2) · 121 Stat. 823

    Amended · 21 U.S.C. § 379j(h)(4)

    Pub. L. 110–85, § 212(h)(2), amended par. (4) generally. Prior to amendment, text read as follows: “Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.”

    Source evidence

    Code amendment note
    Subsec. (h)(4). Pub. L. 110–85, § 212(h)(2), amended par. (4) generally. Prior to amendment, text read as follows: “Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.”

    Enacted provision · exact public law section
    (2) Offset.— Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is amended to read as follows: “(4) Offset.— If the cumulative amount of fees collected during fiscal years 2008, 2009, and 2010, added to the amount estimated to be collected for fiscal year 2011, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2011, exceeds the amount of fees specified in aggregate in paragraph (3) for these four fiscal years, the aggregate amount in excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2012.” .

67. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(a)(1) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379j(a)(1)

    Pub. L. 112–144, § 203(a)(1), substituted “fiscal year 2013” for “fiscal year 2008”

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 112–144, § 203(a)(1), substituted “fiscal year 2013” for “fiscal year 2008”.

    Enacted provision · exact public law section
    (1) in paragraph (1), by striking “fiscal year 2008” and inserting “fiscal year 2013”;

68. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(a)(2)(A) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379j(a)(2)(A)

       Pub. L. 112–144, § 203(a)(2)(A), substituted “subsections (d), (e), and (f)” for “subsections (d) and (e)” in introductory provisions

    2. Substituted · 21 U.S.C. § 379j(a)(2)(A)

       Pub. L. 112–144, § 203(a)(2)(A), substituted “October 1, 2012” for “October 1, 2002” in introductory provisions

    3. Substituted · 21 U.S.C. § 379j(a)(2)(A)

       Pub. L. 112–144, § 203(a)(2)(A), substituted “subsection (c)” for “subsection (c)(1)” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 112–144, § 203(a)(2)(A), substituted “subsections (d), (e), and (f)” for “subsections (d) and (e)”, “October 1, 2012” for “October 1, 2002”, and “subsection (c)” for “subsection (c)(1)” in introductory provisions.

    Enacted provision · exact public law section
    (A) in the matter preceding clause (i)— (i) by striking “subsections (d) and (e)” and inserting “subsections (d), (e), and (f)”; (ii) by striking “October 1, 2002” and inserting “October 1, 2012”; and (iii) by striking “subsection (c)(1)” and inserting “subsection (c)”; and

69. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(a)(2)(B) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379j(a)(2)(A)(viii)

    Pub. L. 112–144, § 203(a)(2)(B), substituted “2” for “1.84”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(viii). Pub. L. 112–144, § 203(a)(2)(B), substituted “2” for “1.84”.

    Enacted provision · exact public law section
    (B) in clause (viii), by striking “1.84” and inserting “2”; and

70. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(a)(3)(A) · 126 Stat. 993

    Inserted · 21 U.S.C. § 379j(a)(3)(A)

    Pub. L. 112–144, § 203(a)(3)(A), inserted “and subsection (f)” after “subparagraph (B)”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(A). Pub. L. 112–144, § 203(a)(3)(A), inserted “and subsection (f)” after “subparagraph (B)”.

    Enacted provision · exact public law section
    (A) in subparagraph (A), by inserting “and subsection (f)” after “subparagraph (B)”; and

71. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(a)(3)(B) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379j(a)(3)(C)

       Pub. L. 112–144, § 203(a)(3)(B), substituted “later of—” for “initial registration of the establishment or upon the annual registration under section 360 of this title.”

    2. Added · 21 U.S.C. § 379j(a)(3)(C)

       Pub. L. 112–144, § 203(a)(3)(B), added cls. (i) and (ii)

    Source evidence

    Code amendment note
    Subsec. (a)(3)(C). Pub. L. 112–144, § 203(a)(3)(B), substituted “later of—” for “initial registration of the establishment or upon the annual registration under section 360 of this title.” and added cls. (i) and (ii).

    Enacted provision · exact public law section
    (B) in subparagraph (C), by striking “initial registration” and all that follows through “section 510.” and inserting “later of— “(i) the initial or annual registration (as applicable) of the establishment under section 510; or “(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.” .

72. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(b) · 126 Stat. 993

    Amended · 21 U.S.C. § 379j(b)

    Pub. L. 112–144, § 203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2008 to 2012

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 112–144, § 203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2008 to 2012.

    Enacted provision · exact public law section
    (b) Fee Amounts.— Section 738(b) (21 U.S.C. 379j(b)) is amended to read as follows: “(b) Fee Amounts.— “(1) In general.— Subject to subsections (c), (d), (e), (f), and (i), for each of fiscal years 2013 through 2017, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3). “(2) Base fee amounts specified.— For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: “Fee TypeFiscal Year 2013Fiscal Year 2014Fiscal Year 2015Fiscal Year 2016Fiscal Year 2017 Premarket Application$248,000$252,960$258,019$263,180$268,443 Establishment Registration$2,575$3,200$3,750$3,872$3,872 “(3) Total revenue amounts specified.— For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: “(A) $97,722,301 for fiscal year 2013. “(B) $112,580,497 for fiscal year 2014. “(C) $125,767,107 for fiscal year 2015. “(D) $129,339,949 for fiscal year 2016. “(E) $130,184,348 for fiscal year 2017.” .

73. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(c) · 126 Stat. 993

    1. Inserted · 21 U.S.C. § 379j(c)

       Pub. L. 112–144, § 203(c), inserted “; adjustments” after “setting” in heading

    2. Added · 21 U.S.C. § 379j(c)

       Pub. L. 112–144, § 203(c), added pars. (1) to (3)

    3. Redesignated · 21 U.S.C. § 379j(c)

       Pub. L. 112–144, § 203(c), redesignated former pars. (3) and (4) as (4) and (5), respectively

    4. Struck · 21 U.S.C. § 379j(c)

       Pub. L. 112–144, § 203(c), struck out former pars. (1) and (2) which related to annual publication and adjustment of fees

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 112–144, § 203(c), inserted “; adjustments” after “setting” in heading, added pars. (1) to (3), redesignated former pars. (3) and (4) as (4) and (5), respectively, and struck out former pars. (1) and (2) which related to annual publication and adjustment of fees.

    Enacted provision · exact public law section
    (c) Annual Fee Setting; Adjustments.— Section 738(c) (21 U.S.C. 379j(c)) is amended— (1) in the subsection heading, by inserting “; Adjustments” after “Setting”; (2) by striking paragraphs (1) and (2); (3) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and (4) by inserting before paragraph (4), as so redesignated, the following: “(1) In general.— Time period. Federal Register, publication. The Secretary shall, 60 days before the start of each fiscal year after September 30, 2012, establish fees under subsection (a), based on amounts specified under subsection (b) and the adjustments provided under this subsection, and publish such fees, and the rationale for any adjustments to such fees, in the Federal Register. “(2) Inflation adjustments.— “(A) Adjustment to total revenue amounts.— For fiscal year 2014 and each subsequent fiscal year, the Secretary shall adjust the total revenue amount specified in subsection (b)(3) for such fiscal year by multiplying such amount by the applicable inflation adjustment under subparagraph (B) for such year. “(B) Applicable inflation adjustment to total revenue amounts.— The applicable inflation adjustment for a fiscal year is— “(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and “(ii) for fiscal year 2015 and each subsequent fiscal year, the product of— “(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and “(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014. “(C) Base inflation adjustment to total revenue amounts.— “(i) In general.— Subject to further adjustment under clause (ii), the base inflation adjustment for a fiscal year is the sum of one plus— “(I) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by 0.60; and “(II) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by 0.40. “(ii) Limitations.— For purposes of subparagraph (B), if the base inflation adjustment for a fiscal year under clause (i)— “(I) is less than 1, such adjustment shall be considered to be equal to 1; or “(II) is greater than 1.04, such adjustment shall be considered to be equal to 1.04. “(D) Adjustment to base fee amounts.— For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A). “(3) Volume-based adjustments to establishment registration base fees.— For each of fiscal years 2014 through 2017, after the base fee amounts specified in subsection (b)(2) are adjusted under paragraph (2)(D), the base establishment registration fee amounts specified in such subsection shall be further adjusted, as the Secretary estimates is necessary in order for total fee collections for such fiscal year to generate the total revenue amounts, as adjusted under paragraph (2).” .

74. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(d) · 126 Stat. 993

    1. Added · 21 U.S.C. § 379j(f)(h)

       Pub. L. 112–144, § 203(d), added subsec. (f)

    2. Redesignated · 21 U.S.C. § 379j(f)(h)

       Pub. L. 112–144, § 203(d), redesignated former subsecs. (f) and (g) as (g) and (h), respectively. Former subsec. (h) redesignated (i)

    Source evidence

    Code amendment note
    Subsecs. (f) to (h). Pub. L. 112–144, § 203(d), added subsec. (f) and redesignated former subsecs. (f) and (g) as (g) and (h), respectively. Former subsec. (h) redesignated (i).

    Enacted provision · exact public law section
    (d) Fee Waiver or Reduction.— Section 738 (21 U.S.C. 379j) is amended by— (1) redesignating subsections (f) through (k) as subsections (g) through (l), respectively; and (2) by inserting after subsection (e) the following new subsection: “(f) Fee Waiver or Reduction.— “(1) In general.— The Secretary may, at the Secretary’s sole discretion, grant a waiver or reduction of fees under subsection (a)(2) or (a)(3) if the Secretary finds that such waiver or reduction is in the interest of public health. “(2) Limitation.— The sum of all fee waivers or reductions granted by the Secretary in any fiscal year under paragraph (1) shall not exceed 2 percent of the total fee revenue amounts established for such year under subsection (c). “(3) Duration.— The authority provided by this subsection terminates October 1, 2017.” .

75. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(e) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379j(h)(1)(A)

    Pub. L. 112–144, § 203(e), substituted “$280,587,000” for “$205,720,000”

    Source evidence

    Code amendment note
    Subsec. (h)(1)(A). Pub. L. 112–144, § 203(e), substituted “$280,587,000” for “$205,720,000”.

    Enacted provision · exact public law section
    (e) Conditions.— Section 738(h)(1)(A) (21 U.S.C. 379j(h)(1)(A)), as redesignated by subsection (d)(1), is amended by striking “$205,720,000” and inserting “$280,587,000”.

76. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(d)(1) · 126 Stat. 993

    Redesignated · 21 U.S.C. § 379j(i)

    Pub. L. 112–144, § 203(d)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 112–144, § 203(d)(1), redesignated subsec. (h) as (i). Former subsec. (i) redesignated (j).

    Enacted provision · exact public law section
    (1) redesignating subsections (f) through (k) as subsections (g) through (l), respectively; and

77. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(f)(1) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379j(i)(1)

    Pub. L. 112–144, § 203(f)(1), substituted “Subject to paragraph (2)(C), fees authorized” for “Fees authorized”

    Source evidence

    Code amendment note
    Subsec. (i)(1). Pub. L. 112–144, § 203(f)(1), substituted “Subject to paragraph (2)(C), fees authorized” for “Fees authorized”.

    Enacted provision · exact public law section
    (1) in paragraph (1), by striking “Fees authorized” and inserting “Subject to paragraph (2)(C), fees authorized”;

78. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(f)(2)(A)(i) · 126 Stat. 993

    Substituted · 21 U.S.C. § 379j(i)(2)(A)(i)

    Pub. L. 112–144, § 203(f)(2)(A)(i), substituted “subject to subparagraph (C), shall be collected and available” for “shall be retained”

    Source evidence

    Code amendment note
    Subsec. (i)(2)(A)(i). Pub. L. 112–144, § 203(f)(2)(A)(i), substituted “subject to subparagraph (C), shall be collected and available” for “shall be retained”.

    Enacted provision · exact public law section
    (i) in clause (i), by striking “shall be retained” and inserting “subject to subparagraph (C), shall be collected and available”; and

79. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(f)(2)(A)(ii) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379j(i)(2)(A)(ii)

       Pub. L. 112–144, § 203(f)(2)(A)(ii), substituted “shall only be available” for “shall only be collected and available”

    2. Substituted · 21 U.S.C. § 379j(i)(2)(A)(ii)

       Pub. L. 112–144, § 203(f)(2)(A)(ii), substituted “fiscal year 2009” for “fiscal year 2002”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 112–144, § 203(f)(2)(A)(ii), substituted “shall only be available” for “shall only be collected and available” and “fiscal year 2009” for “fiscal year 2002”.

    Enacted provision · exact public law section
    (ii) in clause (ii)— (I) by striking “collected and” after “shall only be”; and (II) by striking “fiscal year 2002” and inserting “fiscal year 2009”; and

80. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(f)(2)(B) · 126 Stat. 993

    Added · 21 U.S.C. § 379j(i)(2)(C)

    Pub. L. 112–144, § 203(f)(2)(B), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (i)(2)(C). Pub. L. 112–144, § 203(f)(2)(B), added subpar. (C).

    Enacted provision · exact public law section
    (B) by adding at the end, the following: “(C) Provision for early payments.— Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.” ;

81. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(f)(3) · 126 Stat. 993

    Amended · 21 U.S.C. § 379j(i)(3)

    Pub. L. 112–144, § 203(f)(3), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2008 to 2012

    Source evidence

    Code amendment note
    Subsec. (i)(3). Pub. L. 112–144, § 203(f)(3), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2008 to 2012.

    Enacted provision · exact public law section
    (3) by amending paragraph (3) to read as follows: “(3) Authorizations of appropriations.— For each of the fiscal years 2013 through 2017, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4).” ; and

82. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(f)(4) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 379j(i)(4)

       Pub. L. 112–144, § 203(f)(4), substituted “fiscal years 2013, 2014, and 2015” for “fiscal years 2008, 2009, and 2010”

    2. Substituted · 21 U.S.C. § 379j(i)(4)

       Pub. L. 112–144, § 203(f)(4), substituted “fiscal year 2016” for “fiscal year 2011”

    3. Substituted · 21 U.S.C. § 379j(i)(4)

       Pub. L. 112–144, § 203(f)(4), substituted “June 30, 2016” for “June 30, 2011”

    4. Substituted · 21 U.S.C. § 379j(i)(4)

       Pub. L. 112–144, § 203(f)(4), substituted “the cumulative amount appropriated pursuant to” for “the amount of fees specified in aggregate in”

    5. Substituted · 21 U.S.C. § 379j(i)(4)

       Pub. L. 112–144, § 203(f)(4), substituted “fiscal year 2017” for “fiscal year 2012”

    6. Struck · 21 U.S.C. § 379j(i)(4)

       Pub. L. 112–144, § 203(f)(4), struck out “aggregate amount in” before “excess shall be credited”

    Source evidence

    Code amendment note
    Subsec. (i)(4). Pub. L. 112–144, § 203(f)(4), substituted “fiscal years 2013, 2014, and 2015” for “fiscal years 2008, 2009, and 2010”, “fiscal year 2016” for “fiscal year 2011”, “June 30, 2016” for “June 30, 2011”, “the cumulative amount appropriated pursuant to” for “the amount of fees specified in aggregate in”, and “fiscal year 2017” for “fiscal year 2012” and struck out “aggregate amount in” before “excess shall be credited”.

    Enacted provision · exact public law section
    (4) in paragraph (4)— (A) by striking “fiscal years 2008, 2009, and 2010” and inserting “fiscal years 2013, 2014, and 2015”; (B) by striking “fiscal year 2011” and inserting “fiscal year 2016”; (C) by striking “June 30, 2011” and inserting “June 30, 2016”; (D) by striking “the amount of fees specified in aggregate in” and inserting “the cumulative amount appropriated pursuant to”; (E) by striking “aggregate amount in” before “excess shall be credited”; and (F) by striking “fiscal year 2012” and inserting “fiscal year 2017”.

83. 2012

    Medical Device User Fee Amendments of 2012

    Pub. L. 112–144 § 203(d)(1) · 126 Stat. 993

    Redesignated · 21 U.S.C. § 379j(j)(l)

    Pub. L. 112–144, § 203(d)(1), redesignated subsecs. (i) to (k) as (j) to (l), respectively

    Source evidence

    Code amendment note
    Subsecs. (j) to (l). Pub. L. 112–144, § 203(d)(1), redesignated subsecs. (i) to (k) as (j) to (l), respectively.

    Enacted provision · exact public law section
    (1) redesignating subsections (f) through (k) as subsections (g) through (l), respectively; and

84. 2012

    FDA User Fee Corrections Act of 2012

    Pub. L. 112–193 § 2(b)(1) · 126 Stat. 1443

    Substituted · 21 U.S.C. § 379j(i)(2)(A)(ii)

    Pub. L. 112–193 substituted “shall be available” for “shall only be available”

    Source evidence

    Code amendment note
    Subsec. (i)(2)(A)(ii). Pub. L. 112–193 substituted “shall be available” for “shall only be available”.

    Enacted provision · exact public law section
    (1) in section 738(i)(2)(A)(ii), 21 USC 379j. by striking “shall only be available” and inserting “shall be available”;

85. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(a)(1) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(a)(1)

    Pub. L. 115–52, § 203(a)(1), substituted “fiscal year 2018” for “fiscal year 2013”

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 115–52, § 203(a)(1), substituted “fiscal year 2018” for “fiscal year 2013”.

    Enacted provision · exact public law section
    (1) in paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

86. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(f)(2)(B)(ii) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(a)(2)(A)

    Pub. L. 115–52, § 203(f)(2)(B)(ii), substituted “(d) and (e)” for “(d), (e), and (f)” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A). Pub. L. 115–52, § 203(f)(2)(B)(ii), substituted “(d) and (e)” for “(d), (e), and (f)” in introductory provisions.

    Enacted provision · exact public law section
    (ii) in subsection (a)(2)(A), by striking “(d), (e), and (f)” and inserting “(d) and (e)”; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

87. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(a)(2)(A)(i) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(a)(2)(A)

    Pub. L. 115–52, § 203(a)(2)(A)(i), substituted “October 1, 2017” for “October 1, 2012” in introductory provisions

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 115–52, § 203(a)(2)(A)(i), substituted “October 1, 2017” for “October 1, 2012” in introductory provisions.

    Enacted provision · exact public law section
    (i) in the matter preceding clause (i), by striking “October 1, 2012” and inserting “October 1, 2017”;

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

88. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(a)(2)(A)(ii) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(a)(2)(A)(viii)

    Pub. L. 115–52, § 203(a)(2)(A)(ii), substituted “3.4 percent” for “2 percent”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(viii). Pub. L. 115–52, § 203(a)(2)(A)(ii), substituted “3.4 percent” for “2 percent”.

    Enacted provision · exact public law section
    (ii) in clause (viii), by striking “2” and inserting “3.4”; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

89. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(a)(2)(A)(iii) · 131 Stat. 1005

    Added · 21 U.S.C. § 379j(a)(2)(A)(xi)

    Pub. L. 115–52, § 203(a)(2)(A)(iii), added cl. (xi)

    Source evidence

    Code amendment note
    Subsec. (a)(2)(A)(xi). Pub. L. 115–52, § 203(a)(2)(A)(iii), added cl. (xi).

    Enacted provision · exact public law section
    (iii) by adding at the end the following new clause: “(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).” ; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

90. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(a)(2)(B) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(a)(2)(B)(v)(I)

    Pub. L. 115–52, § 203(a)(2)(B), substituted “premarket notification submission, or de novo classification request” for “or premarket notification submission”

    Source evidence

    Code amendment note
    Subsec. (a)(2)(B)(v)(I). Pub. L. 115–52, § 203(a)(2)(B), substituted “premarket notification submission, or de novo classification request” for “or premarket notification submission”.

    Enacted provision · exact public law section
    (B) in subparagraph (B)(v)(I), by striking “or premarket notification submission” and inserting “premarket notification submission, or de novo classification request”.

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

91. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(f)(2)(B)(iii) · 131 Stat. 1005

    Struck · 21 U.S.C. § 379j(a)(3)(A)

    Pub. L. 115–52, § 203(f)(2)(B)(iii), struck out “and subsection (f)” after “subparagraph (B)”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(A). Pub. L. 115–52, § 203(f)(2)(B)(iii), struck out “and subsection (f)” after “subparagraph (B)”.

    Enacted provision · exact public law section
    (iii) in subsection (a)(3)(A), by striking “and subsection (f)”.

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

92. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(b) · 131 Stat. 1005

    Amended · 21 U.S.C. § 379j(b)

    Pub. L. 115–52, § 203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2013 to 2017

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 115–52, § 203(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) listed fee amounts for fiscal years 2013 to 2017.

    Enacted provision · exact public law section
    (b) Fee Amounts.— Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows: “(b) Fee Amounts.— “(1) In general.— Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3). “(2) Base fee amounts specified.— For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: “Fee TypeFiscal Year 2018Fiscal Year 2019Fiscal Year 2020Fiscal Year 2021Fiscal Year 2022 Premarket Application$294,000$300,000$310,000$328,000$329,000 Establishment Registration$4,375$4,548$4,760$4,975$4,978 “(3) Total revenue amounts specified.— For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: “(A) $183,280,756 for fiscal year 2018. “(B) $190,654,875 for fiscal year 2019. “(C) $200,132,014 for fiscal year 2020. “(D) $211,748,789 for fiscal year 2021. “(E) $213,687,660 for fiscal year 2022.” .

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

93. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(c)(1) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(c)(1)

    Pub. L. 115–52, § 203(c)(1), substituted “2017” for “2012”

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 115–52, § 203(c)(1), substituted “2017” for “2012”.

    Enacted provision · exact public law section
    (1) in paragraph (1), by striking “2012” and inserting “2017”;

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

94. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(c)(2)(A) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(c)(2)(A)

    Pub. L. 115–52, § 203(c)(2)(A), substituted “2018” for “2014”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(A). Pub. L. 115–52, § 203(c)(2)(A), substituted “2018” for “2014”.

    Enacted provision · exact public law section
    (A) in subparagraph (A), by striking “2014” and inserting “2018”;

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

95. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(c)(2)(B) · 131 Stat. 1005

    1. Added · 21 U.S.C. § 379j(c)(2)(B)

       Pub. L. 115–52, § 203(c)(2)(B), added subpar. (B)

    2. Struck · 21 U.S.C. § 379j(c)(2)(B)

       Pub. L. 115–52, § 203(c)(2)(B), struck out former subpar. (B). Prior to amendment, text read as follows: “The applicable inflation adjustment for a fiscal year is—

    Source evidence

    Code amendment note
    Subsec. (c)(2)(B). Pub. L. 115–52, § 203(c)(2)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: “The applicable inflation adjustment for a fiscal year is—

    “(i) for fiscal year 2014, the base inflation adjustment under subparagraph (C) for such fiscal year; and “(ii) for fiscal year 2015 and each subsequent fiscal year, the product of— “(I) the base inflation adjustment under subparagraph (C) for such fiscal year; and “(II) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2014.”

    Enacted provision · exact public law section
    (B) by striking subparagraph (B) and inserting the following new subparagraph: “(B) Applicable inflation adjustment.— The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of— “(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and “(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016.” ;

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

96. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(c)(2)(C) · 131 Stat. 1005

    Struck · 21 U.S.C. § 379j(c)(2)(C)

    Pub. L. 115–52, § 203(c)(2)(C), struck out “to total revenue amounts” after “adjustment” in heading

    Source evidence

    Code amendment note
    Subsec. (c)(2)(C). Pub. L. 115–52, § 203(c)(2)(C), struck out “to total revenue amounts” after “adjustment” in heading.

    Enacted provision · exact public law section
    (C) in subparagraph (C), in the heading, by striking “to total revenue amounts”; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

97. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(c)(2)(D) · 131 Stat. 1005

    Amended · 21 U.S.C. § 379j(c)(2)(D)

    Pub. L. 115–52, § 203(c)(2)(D), amended subpar. (D) generally. Prior to amendment, text read as follows: “For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(D). Pub. L. 115–52, § 203(c)(2)(D), amended subpar. (D) generally. Prior to amendment, text read as follows: “For each of fiscal years 2014 through 2017, the base fee amounts specified in subsection (b)(2) shall be adjusted as needed, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).”

    Enacted provision · exact public law section
    (D) by amending subparagraph (D) to read as follows: “(D) Adjustment to base fee amounts.— For each of fiscal years 2018 through 2022, the Secretary shall— “(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and “(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).” ; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

98. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(c)(3) · 131 Stat. 1005

    1. Substituted · 21 U.S.C. § 379j(c)(3)

       Pub. L. 115–52, § 203(c)(3), substituted “2018 through 2022” for “2014 through 2017”

    2. Substituted · 21 U.S.C. § 379j(c)(3)

       Pub. L. 115–52, § 203(c)(3), substituted “increased” for “further adjusted”

    Source evidence

    Code amendment note
    Subsec. (c)(3). Pub. L. 115–52, § 203(c)(3), substituted “2018 through 2022” for “2014 through 2017” and “increased” for “further adjusted”.

    Enacted provision · exact public law section
    (3) in paragraph (3)— (A) by striking “2014 through 2017” and inserting “2018 through 2022”; and (B) by striking “further adjusted” and inserting “increased”.

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

99. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 203(d)(1) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 379j(d)(1)

    Pub. L. 115–52, § 203(d)(1), substituted “specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)” for “specified in clauses (i) through (v) and clauses (vii), (ix), and (x)”

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 115–52, § 203(d)(1), substituted “specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)” for “specified in clauses (i) through (v) and clauses (vii), (ix), and (x)”.

    Enacted provision · exact public law section
    (1) in paragraph (1), by striking “specified in clauses (i) through (v) and clauses (vii), (ix), and (x)” and inserting “specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)”; and

    Effective date note
    Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

100. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(d)(2) · 131 Stat. 1005

     1. Substituted · 21 U.S.C. § 379j(d)(2)(C)(i)

        Pub. L. 115–52, § 203(d)(2), substituted “supplement,” for “supplement, or”

     2. Inserted · 21 U.S.C. § 379j(d)(2)(C)(i)

        Pub. L. 115–52, § 203(d)(2), inserted “, or a de novo classification request” after “class III device”

     Source evidence

     Code amendment note
     Subsec. (d)(2)(C)(i). Pub. L. 115–52, § 203(d)(2), substituted “supplement,” for “supplement, or” and inserted “, or a de novo classification request” after “class III device”.

     Enacted provision · exact public law section
     (2) in paragraph (2)(C)— (A) by striking “supplement, or” and inserting “supplement,”; and (B) by inserting “, or a de novo classification request” after “class III device”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

101. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(e) · 131 Stat. 1005

     Substituted · 21 U.S.C. § 379j(e)(2)(C)

     Pub. L. 115–52, § 203(e), substituted “25 percent” for “50 percent”

     Source evidence

     Code amendment note
     Subsec. (e)(2)(C). Pub. L. 115–52, § 203(e), substituted “25 percent” for “50 percent”.

     Enacted provision · exact public law section
     (e) Small Businesses; Fee Reduction Regarding Premarket Notification Submissions.— Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking “50” and inserting “25”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

102. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(f)(1) · 131 Stat. 1005

     1. Redesignated · 21 U.S.C. § 379j(f)

        Pub. L. 115–52, § 203(f)(1), (2)(B)(i), redesignated subsec. (g) as (f)

     2. Struck · 21 U.S.C. § 379j(f)

        Pub. L. 115–52, § 203(f)(1), (2)(B)(i), struck out former subsec. (f) which authorized the Secretary to grant waivers or reductions of fees under subsec. (a)(2) or (3) until Oct. 1, 2017

     Source evidence

     Code amendment note
     Subsec. (f). Pub. L. 115–52, § 203(f)(1), (2)(B)(i), redesignated subsec. (g) as (f) and struck out former subsec. (f) which authorized the Secretary to grant waivers or reductions of fees under subsec. (a)(2) or (3) until Oct. 1, 2017.

     Enacted provision · exact public law section
     (1) Repeal.— Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection (f).

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

103. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(g) · 131 Stat. 1005

     1. Substituted · 21 U.S.C. § 379j(f)(1)

        Pub. L. 115–52, § 203(g), substituted “periodic reporting concerning a class III device, or de novo classification request” for “or periodic reporting concerning a class III device”

     2. Substituted · 21 U.S.C. § 379j(f)(1)

        Pub. L. 115–52, § 203(g), substituted “all such fees” for “all fees”

     Source evidence

     Code amendment note
     Subsec. (f)(1). Pub. L. 115–52, § 203(g), substituted “periodic reporting concerning a class III device, or de novo classification request” for “or periodic reporting concerning a class III device” and “all such fees” for “all fees”.

     Enacted provision · exact public law section
     (g) Effect of Failure To Pay Fees.— Subsection (f)(1), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— (1) by striking “or periodic reporting concerning a class III device” and inserting “periodic reporting concerning a class III device, or de novo classification request”; and (2) by striking “all fees” and inserting “all such fees”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

104. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(f)(2)(B)(i) · 131 Stat. 1005

     Redesignated · 21 U.S.C. § 379j(g)

     Pub. L. 115–52, § 203(f)(2)(B)(i), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f)

     Source evidence

     Code amendment note
     Subsec. (g). Pub. L. 115–52, § 203(f)(2)(B)(i), redesignated subsec. (h) as (g). Former subsec. (g) redesignated (f).

     Enacted provision · exact public law section
     (i) by redesignating subsections (g) through (l) as subsections (f) through (k);

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

105. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(h) · 131 Stat. 1005

     Substituted · 21 U.S.C. § 379j(g)(1)(A)

     Pub. L. 115–52, § 203(h), substituted “$320,825,000” for “$280,587,000”

     Source evidence

     Code amendment note
     Subsec. (g)(1)(A). Pub. L. 115–52, § 203(h), substituted “$320,825,000” for “$280,587,000”.

     Enacted provision · exact public law section
     (h) Conditions.— Subsection (g)(1)(A), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking “$280,587,000” and inserting “$320,825,000”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

106. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(f)(2)(B)(i) · 131 Stat. 1005

     Redesignated · 21 U.S.C. § 379j(h)

     Pub. L. 115–52, § 203(f)(2)(B)(i), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g)

     Source evidence

     Code amendment note
     Subsec. (h). Pub. L. 115–52, § 203(f)(2)(B)(i), redesignated subsec. (i) as (h). Former subsec. (h) redesignated (g).

     Enacted provision · exact public law section
     (i) by redesignating subsections (g) through (l) as subsections (f) through (k);

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

107. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(i)(1) · 131 Stat. 1005

     1. Substituted · 21 U.S.C. § 379j(h)(3)

        Pub. L. 115–52, § 203(i)(1), substituted “2018 through 2022” for “2013 through 2017”

     2. Substituted · 21 U.S.C. § 379j(h)(3)

        Pub. L. 115–52, § 203(i)(1), substituted “subsection (c).” for “subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4).”

     Source evidence

     Code amendment note
     Subsec. (h)(3). Pub. L. 115–52, § 203(i)(1), substituted “2018 through 2022” for “2013 through 2017” and “subsection (c).” for “subsection (c) and, for fiscal year 2017 only, as further adjusted under paragraph (4).”

     Enacted provision · exact public law section
     (1) in paragraph (3)— (A) by striking “2013 through 2017” and inserting “2018 through 2022”; and (B) by striking “subsection (c)” and all that follows through the period at the end and inserting “subsection (c).”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

108. 2017

     FDA Reauthorization Act of 2017

     Pub. L. 115–52 § 905(b)(2) · 131 Stat. 1005

     1. Amended · 21 U.S.C. § 379j(h)(3)

        Pub. L. 115–52, § 905(b)(2), as amended by Pub. L. 117–328, § 3625(e)(1)

     2. Redesignated · 21 U.S.C. § 379j(h)(3)

        Pub. L. 115–52, § 905(b)(2), as added par. (3), effective Aug. 18, 2017. Subsec. (h) subsequently redesignated (g) effective Oct. 1, 2017, by Pub. L. 115–52, § 203(f)(2)(B)(i). See Amendment note above

     Target inherited from the preceding amendment note.

     Source evidence

     Code amendment note
     Pub. L. 115–52, § 905(b)(2), as amended by Pub. L. 117–328, § 3625(e)(1), added par. (3), effective Aug. 18, 2017. Subsec. (h) subsequently redesignated (g) effective Oct. 1, 2017, by Pub. L. 115–52, § 203(f)(2)(B)(i). See Amendment note above.

     Enacted provision · exact public law section
     (2) MDUFA.— Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the end the following: “(3) Limitation.— Beginning on October 1, 2023, the authorities under section 737(9)(C) shall include only leasing and necessary scientific equipment.” .

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

109. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(i)(2) · 131 Stat. 1005

     Struck · 21 U.S.C. § 379j(h)(4)

     Pub. L. 115–52, § 203(i)(2), struck out par. (4). Text read as follows: “If the cumulative amount of fees collected during fiscal years 2013, 2014, and 2015, added to the amount estimated to be collected for fiscal year 2016, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2016, exceeds the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017.”

     Source evidence

     Code amendment note
     Subsec. (h)(4). Pub. L. 115–52, § 203(i)(2), struck out par. (4). Text read as follows: “If the cumulative amount of fees collected during fiscal years 2013, 2014, and 2015, added to the amount estimated to be collected for fiscal year 2016, which estimate shall be based upon the amount of fees received by the Secretary through June 30, 2016, exceeds the cumulative amount appropriated pursuant to paragraph (3) for these four fiscal years, the excess shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017.”

     Enacted provision · exact public law section
     (2) by striking paragraph (4).

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

110. 2017

     Medical Device User Fee Amendments of 2017

     Pub. L. 115–52 § 203(f)(2)(B)(i) · 131 Stat. 1005

     Redesignated · 21 U.S.C. § 379j(i)(l)

     Pub. L. 115–52, § 203(f)(2)(B)(i), redesignated subsecs. (j) to (l) as (i) to (k), respectively. Former subsec. (i) redesignated (h)

     Source evidence

     Code amendment note
     Subsecs. (i) to (l). Pub. L. 115–52, § 203(f)(2)(B)(i), redesignated subsecs. (j) to (l) as (i) to (k), respectively. Former subsec. (i) redesignated (h).

     Enacted provision · exact public law section
     (i) by redesignating subsections (g) through (l) as subsections (f) through (k);

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

111. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(a)(1) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(a)(1)

     Pub. L. 117–180, § 2003(a)(1), substituted “fiscal year 2023” for “fiscal year 2018”

     Source evidence

     Code amendment note
     Subsec. (a)(1). Pub. L. 117–180, § 2003(a)(1), substituted “fiscal year 2023” for “fiscal year 2018”.

     Enacted provision · exact public law section
     (1) in paragraph (1), by striking “fiscal year 2018” and inserting “fiscal year 2023”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

112. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(a)(2)(A)(i) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(a)(2)(A)

     Pub. L. 117–180, § 2003(a)(2)(A)(i), substituted “October 1, 2022” for “October 1, 2017” in introductory provisions

     Source evidence

     Code amendment note
     Subsec. (a)(2)(A). Pub. L. 117–180, § 2003(a)(2)(A)(i), substituted “October 1, 2022” for “October 1, 2017” in introductory provisions.

     Enacted provision · exact public law section
     (i) in the matter preceding clause (i), by striking “October 1, 2017” and inserting “October 1, 2022”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

113. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(a)(2)(A)(ii) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(a)(2)(A)(iii)

     Pub. L. 117–180, § 2003(a)(2)(A)(ii), substituted “80 percent” for “75 percent”

     Source evidence

     Code amendment note
     Subsec. (a)(2)(A)(iii). Pub. L. 117–180, § 2003(a)(2)(A)(ii), substituted “80 percent” for “75 percent”.

     Enacted provision · exact public law section
     (ii) in clause (iii), by striking “75 percent” and inserting “80 percent”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

114. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(a)(2)(A)(iii) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(a)(2)(A)(viii)

     Pub. L. 117–180, § 2003(a)(2)(A)(iii), substituted “4.5 percent” for “3.4 percent”

     Source evidence

     Code amendment note
     Subsec. (a)(2)(A)(viii). Pub. L. 117–180, § 2003(a)(2)(A)(iii), substituted “4.5 percent” for “3.4 percent”.

     Enacted provision · exact public law section
     (iii) in clause (viii), by striking “3.4 percent” and inserting “4.5 percent”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

115. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(a)(2)(B) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(a)(2)(B)(iii)

     Pub. L. 117–180, § 2003(a)(2)(B), substituted “premarket notification submission, or de novo classification request” for “or premarket notification submission”

     Source evidence

     Code amendment note
     Subsec. (a)(2)(B)(iii). Pub. L. 117–180, § 2003(a)(2)(B), substituted “premarket notification submission, or de novo classification request” for “or premarket notification submission”.

     Enacted provision · exact public law section
     (B) in subparagraph (B)(iii), by striking “or premarket notification submission” and inserting “premarket notification submission, or de novo classification request”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

116. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(a)(2)(C) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(a)(2)(C)

     Pub. L. 117–180, § 2003(a)(2)(C), substituted “periodic reporting concerning a class III device, or de novo classification request” for “or periodic reporting concerning a class III device”

     Source evidence

     Code amendment note
     Subsec. (a)(2)(C). Pub. L. 117–180, § 2003(a)(2)(C), substituted “periodic reporting concerning a class III device, or de novo classification request” for “or periodic reporting concerning a class III device”.

     Enacted provision · exact public law section
     (C) in subparagraph (C), by striking “or periodic reporting concerning a class III device” and inserting “periodic reporting concerning a class III device, or de novo classification request”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

117. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(b)(1) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(b)(1)

     Pub. L. 117–180, § 2003(b)(1), substituted “2023 through 2027” for “2018 through 2022”

     Source evidence

     Code amendment note
     Subsec. (b)(1). Pub. L. 117–180, § 2003(b)(1), substituted “2023 through 2027” for “2018 through 2022”.

     Enacted provision · exact public law section
     (1) in paragraph (1), by striking “2018 through 2022” and inserting “2023 through 2027”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

118. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(b)(2) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379j(b)(2)

     Pub. L. 117–180, § 2003(b)(2), amended par. (2) generally. Prior to amendment, par. (2) specified base fee amounts for fiscal years 2018 to 2022

     Source evidence

     Code amendment note
     Subsec. (b)(2). Pub. L. 117–180, § 2003(b)(2), amended par. (2) generally. Prior to amendment, par. (2) specified base fee amounts for fiscal years 2018 to 2022.

     Enacted provision · exact public law section
     (2) by amending paragraph (2) to read as follows: “(2) Base fee amounts specified.— For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows: “Fee TypeFiscal Year 2023Fiscal Year 2024Fiscal Year 2025Fiscal Year 2026Fiscal Year 2027 Premarket Application$425,000$435,000$445,000$455,000$470,000 Establishment Registration$6,250$6,875$7,100$7,575$8,465”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

119. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(b)(3) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379j(b)(3)

     Pub. L. 117–180, § 2003(b)(3), amended par. (3) generally. Prior to amendment, par. (3) specified total revenue amounts for fiscal years 2018 to 2022

     Source evidence

     Code amendment note
     Subsec. (b)(3). Pub. L. 117–180, § 2003(b)(3), amended par. (3) generally. Prior to amendment, par. (3) specified total revenue amounts for fiscal years 2018 to 2022.

     Enacted provision · exact public law section
     (3) by amending paragraph (3) to read as follows: “(3) Total revenue amounts specified.— For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: “(A) $312,606,000 for fiscal year 2023. “(B) $335,750,000 for fiscal year 2024. “(C) $350,746,400 for fiscal year 2025. “(D) $366,486,300 for fiscal year 2026. “(E) $418,343,000 for fiscal year 2027.” .

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

120. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(1) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(1)

     Pub. L. 117–180, § 2003(c)(1), substituted “2022” for “2017”

     Source evidence

     Code amendment note
     Subsec. (c)(1). Pub. L. 117–180, § 2003(c)(1), substituted “2022” for “2017”.

     Enacted provision · exact public law section
     (1) in paragraph (1), by striking “2017” and inserting “2022”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

121. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(2)(A) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(2)(A)

     Pub. L. 117–180, § 2003(c)(2)(A), substituted “2023” for “2018”

     Source evidence

     Code amendment note
     Subsec. (c)(2)(A). Pub. L. 117–180, § 2003(c)(2)(A), substituted “2023” for “2018”.

     Enacted provision · exact public law section
     (A) in subparagraph (A), by striking “2018” and inserting “2023”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

122. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(2)(B)(i) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(2)(B)

     Pub. L. 117–180, § 2003(c)(2)(B)(i), substituted “fiscal year 2023” for “fiscal year 2018” in introductory provisions

     Source evidence

     Code amendment note
     Subsec. (c)(2)(B). Pub. L. 117–180, § 2003(c)(2)(B)(i), substituted “fiscal year 2023” for “fiscal year 2018” in introductory provisions.

     Enacted provision · exact public law section
     (i) in the matter preceding clause (i), by striking “fiscal year 2018” and inserting “fiscal year 2023”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

123. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(2)(B)(ii) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(2)(B)(ii)

     Pub. L. 117–180, § 2003(c)(2)(B)(ii), substituted “fiscal year 2022” for “fiscal year 2016”

     Source evidence

     Code amendment note
     Subsec. (c)(2)(B)(ii). Pub. L. 117–180, § 2003(c)(2)(B)(ii), substituted “fiscal year 2022” for “fiscal year 2016”.

     Enacted provision · exact public law section
     (ii) in clause (ii), by striking “fiscal year 2016” and inserting “fiscal year 2022”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

124. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(2)(C) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(2)(C)(i)(II)

     Pub. L. 117–180, § 2003(c)(2)(C), substituted “Washington-Arlington-Alexandria, DC–VA–MD–WV” for “Washington-Baltimore, DC–MD–VA–WV”

     Source evidence

     Code amendment note
     Subsec. (c)(2)(C)(i)(II). Pub. L. 117–180, § 2003(c)(2)(C), substituted “Washington-Arlington-Alexandria, DC–VA–MD–WV” for “Washington-Baltimore, DC–MD–VA–WV”.

     Enacted provision · exact public law section
     (C) in subparagraph (C), by striking “Washington-Baltimore, DC–MD–VA–WV” and inserting “Washington-Arlington-Alexandria, DC–VA–MD–WV”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

125. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(2)(D) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(2)(D)

     Pub. L. 117–180, § 2003(c)(2)(D), substituted “fiscal years 2023 through 2027” for “fiscal years 2018 through 2022” in introductory provisions

     Source evidence

     Code amendment note
     Subsec. (c)(2)(D). Pub. L. 117–180, § 2003(c)(2)(D), substituted “fiscal years 2023 through 2027” for “fiscal years 2018 through 2022” in introductory provisions.

     Enacted provision · exact public law section
     (D) in subparagraph (D), in the matter preceding clause (i), by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

126. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(3) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(c)(3)

     Pub. L. 117–180, § 2003(c)(3), substituted “2023 through 2027” for “2018 through 2022”

     Source evidence

     Code amendment note
     Subsec. (c)(3). Pub. L. 117–180, § 2003(c)(3), substituted “2023 through 2027” for “2018 through 2022”.

     Enacted provision · exact public law section
     (3) in paragraph (3), by striking “2018 through 2022” and inserting “2023 through 2027”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

127. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(c)(4) · 136 Stat. 2114

     1. Added · 21 U.S.C. § 379j(c)(4)(8)

        Pub. L. 117–180, § 2003(c)(4), (5), added pars. (4) to (6)

     2. Redesignated · 21 U.S.C. § 379j(c)(4)(8)

        Pub. L. 117–180, § 2003(c)(4), (5), redesignated former pars. (4) and (5) as (7) and (8), respectively

     Source evidence

     Code amendment note
     Subsec. (c)(4) to (8). Pub. L. 117–180, § 2003(c)(4), (5), added pars. (4) to (6) and redesignated former pars. (4) and (5) as (7) and (8), respectively.

     Enacted provision · exact public law section
     (4) by redesignating paragraphs (4) and (5) as paragraphs (7) and (8), respectively; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

128. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(d)(1) · 136 Stat. 2114

     Substituted · 21 U.S.C. § 379j(g)(1)(A)

     Pub. L. 117–180, § 2003(d)(1), substituted “$398,566,000” for “$320,825,000”

     Source evidence

     Code amendment note
     Subsec. (g)(1)(A). Pub. L. 117–180, § 2003(d)(1), substituted “$398,566,000” for “$320,825,000”.

     Enacted provision · exact public law section
     (1) in paragraph (1)(A), by striking “$320,825,000” and inserting “$398,566,000”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

129. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(d)(2) · 136 Stat. 2114

     Inserted · 21 U.S.C. § 379j(g)(2)

     Pub. L. 117–180, § 2003(d)(2), inserted “de novo classification requests,” after “class III device,”

     Source evidence

     Code amendment note
     Subsec. (g)(2). Pub. L. 117–180, § 2003(d)(2), inserted “de novo classification requests,” after “class III device,”.

     Enacted provision · exact public law section
     (2) in paragraph (2), by inserting “de novo classification requests,” after “class III device,”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

130. 2022

     Medical Device User Fee Amendments of 2022

     Pub. L. 117–180 § 2003(e) · 136 Stat. 2114

     Amended · 21 U.S.C. § 379j(h)(3)

     Pub. L. 117–180, § 2003(e), amended par. (3) generally. Prior to amendment, text read as follows: “For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c).”

     Source evidence

     Code amendment note
     Subsec. (h)(3). Pub. L. 117–180, § 2003(e), amended par. (3) generally. Prior to amendment, text read as follows: “For each of the fiscal years 2018 through 2022, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount specified under subsection (b)(3) for the fiscal year, as adjusted under subsection (c).”

     Enacted provision · exact public law section
     (e) Crediting and Availability of Fees.— Section 738(h)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended to read as follows: “(3) Authorization of appropriations.— “(A) In general.— For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C). “(B) Revenue amount.— For purposes of this paragraph, the revenue amount for each fiscal year is the sum of— “(i) the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs (2) and (3) of subsection (c); and “(ii) the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable. “(C) Amount of reductions.— For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of— “(i) the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and “(ii) the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.” .

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

131. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3309(a) · 136 Stat. 4459

     1. Amended · 21 U.S.C. § 379j(a)(3)(B)

        Pub. L. 117–328, § 3309(a), designated existing provisions as cl. (i)

     2. Inserted · 21 U.S.C. § 379j(a)(3)(B)

        Pub. L. 117–328, § 3309(a), inserted heading

     3. Added · 21 U.S.C. § 379j(a)(3)(B)

        Pub. L. 117–328, § 3309(a), added cl. (ii)

     Source evidence

     Code amendment note
     Subsec. (a)(3)(B). Pub. L. 117–328, § 3309(a), designated existing provisions as cl. (i), inserted heading, and added cl. (ii).

     Enacted provision · exact public law section
     (a) In General.— Section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended— (1) by striking “No fee” and inserting the following: “(i) In general.— No fee” ; and (2) by adding at the end the following: “(ii) Small businesses fee waiver.— “(I) Definition of small business.— For purposes of this clause, the term ‘small business’ means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. “(II) Waiver.— The Secretary may grant a waiver of the fee required under subparagraph (A) for the annual registration (excluding the initial registration) of an establishment for a year, beginning on October 1, 2024, if the Secretary finds that the establishment is a small business and paying the fee for such year represents a financial hardship to the establishment as determined by the Secretary. “(III) Firms submitting tax returns to the united states internal revenue service.— The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates. “(IV) Firms not submitting tax returns to the united states internal revenue service.— In the Certification. Notice. Federal Register, publication. case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The Statement. establishment shall also submit a statement signed by the head of the establishment’s firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates. “(V) Request for waiver.— An establishment seeking a fee waiver for a year under this clause shall submit supporting information to the Secretary at least 60 days before the fee is required pursuant to subparagraph (C). The decision of the Secretary regarding whether an entity may receive the waiver for such year is not reviewable.” .

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

132. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3309(b) · 136 Stat. 4459

     Inserted · 21 U.S.C. § 379j(d)(2)(B)(iii)

     Pub. L. 117–328, § 3309(b), inserted “, if extant,” after “national taxing authority”

     Source evidence

     Code amendment note
     Subsec. (d)(2)(B)(iii). Pub. L. 117–328, § 3309(b), inserted “, if extant,” after “national taxing authority”.

     Enacted provision · exact public law section
     (b) Taxing Authority.— Section 738(d)(2)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)(2)(B)(iii)) is amended by inserting “, if extant,” after “national taxing authority”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

133. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(d)(1) · 136 Stat. 4459

     Inserted · 21 U.S.C. § 379j(e)(2)(B)(iii)

     Pub. L. 117–328, § 3625(d)(1), inserted “, if extant,” after “national taxing authority”

     Source evidence

     Code amendment note
     Subsec. (e)(2)(B)(iii). Pub. L. 117–328, § 3625(d)(1), inserted “, if extant,” after “national taxing authority”.

     Enacted provision · exact public law section
     (1) in subsection (e)(2)(B)(iii), by inserting “, if extant,” after “national taxing authority”;

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

134. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(e)(1) · 136 Stat. 4459

     Changed · 21 U.S.C. § 379j(g)(3)

     Pub. L. 117–328, § 3625(e)(1), which directed technical correction to directory language of Pub. L. 115–52, § 905(b)(2), was executed by making technical correction to that section as if the amendment were retroactive to the effective date of the amendment by Pub. L. 115–52 to reflect the probable intent of Congress. See 2017 Amendment note below

     Source evidence

     Code amendment note
     Subsec. (g)(3). Pub. L. 117–328, § 3625(e)(1), which directed technical correction to directory language of Pub. L. 115–52, § 905(b)(2), was executed by making technical correction to that section as if the amendment were retroactive to the effective date of the amendment by Pub. L. 115–52 to reflect the probable intent of Congress. See 2017 Amendment note below.

     Enacted provision · exact public law section
     (1) In general.— Section 905(b)(2) of the FDA Reauthorization Act of 2017 (Public Law 115–52) 131 Stat. 1090. is amended by striking “Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is amended” and inserting “Subsection (g) of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as so redesignated by section 203(f)(2)(B)(i), is amended”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

135. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(d)(3) · 136 Stat. 4459

     Substituted · 21 U.S.C. § 379j(g)(3)

     Pub. L. 117–328, § 3625(d)(3), substituted “379i(10)(C) of this title” for “section 379i(9)(C) of this title”

     Target inherited from the preceding amendment note.

     Source evidence

     Code amendment note
     Pub. L. 117–328, § 3625(d)(3), substituted “379i(10)(C) of this title” for “section 379i(9)(C) of this title”.

     Enacted provision · exact public law section
     (3) in subsection (g)(3), by striking “737(9)(C)” and inserting “737(10)(C)”.

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

136. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(d)(2)(A) · 136 Stat. 4459

     1. Substituted · 21 U.S.C. § 379j(h)(2)(A)(ii)

        Pub. L. 117–328, § 3625(d)(2)(A), substituted “shall be available—” for “shall be available to defray”

     2. Amended · 21 U.S.C. § 379j(h)(2)(A)(ii)

        Pub. L. 117–328, § 3625(d)(2)(A), designated remainder of existing provisions as subcl. (I)

     3. Inserted · 21 U.S.C. § 379j(h)(2)(A)(ii)

        Pub. L. 117–328, § 3625(d)(2)(A), inserted “for fiscal year 2023, to defray” before “increases in the costs”

     4. Added · 21 U.S.C. § 379j(h)(2)(A)(ii)

        Pub. L. 117–328, § 3625(d)(2)(A), added subcl. (II)

     Source evidence

     Code amendment note
     Subsec. (h)(2)(A)(ii). Pub. L. 117–328, § 3625(d)(2)(A), substituted “shall be available—” for “shall be available to defray”, designated remainder of existing provisions as subcl. (I), inserted “for fiscal year 2023, to defray” before “increases in the costs”, and added subcl. (II).

     Enacted provision · exact public law section
     (A) in subparagraph (A)(ii)— (i) by striking “shall be available to defray” and inserting the following: “shall be available— “(I) for fiscal year 2023, to defray” ; (ii) by striking the period and inserting “; and”; and (iii) by adding at the end the following: “(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.” ; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

137. 2022

     Food and Drug Omnibus Reform Act of 2022

     Pub. L. 117–328 § 3625(d)(2)(B) · 136 Stat. 4459

     Substituted · 21 U.S.C. § 379j(h)(2)(B)(i)

     Pub. L. 117–328, § 3625(d)(2)(B), substituted “as described in subclause (I) or (II) of such subparagraph, as applicable” for “for the process for the review of device applications” in introductory provisions

     Source evidence

     Code amendment note
     Subsec. (h)(2)(B)(i). Pub. L. 117–328, § 3625(d)(2)(B), substituted “as described in subclause (I) or (II) of such subparagraph, as applicable” for “for the process for the review of device applications” in introductory provisions.

     Enacted provision · exact public law section
     (B) in subparagraph (B)(i), in the matter preceding subclause (I), by striking “for the process for the review of device applications” and inserting “as described in subclause (I) or (II) of such subparagraph, as applicable”; and

     Effective date note
     Pub. L. 117–328, div. FF, title III, § 3625(e)(2), Dec. 29, 2022, 136 Stat. 5882, provided that: “The amendment made by paragraph (1) [amending this section] shall take effect as though included in the enactment of section 905 of the FDA Reauthorization Act of 2017 (Public Law 115–52) [Aug. 18, 2017].” Amendments by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in subsec. (a)(2)(A) of this section received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

204 of 204 references resolved to an enrolled provision