Title 21 — Food and Drugs
Part C · Chapter 9 — Federal Food, Drug, and Cosmetic Act
§ 379i. Definitions
Statutory text
For purposes of this subpart:
The term “premarket application” means—
an application for approval of a device submitted under section 360e(c) of this title or section 262 of title 42; or
a product development protocol described in section 360e(f) of this title.
Such term does not include a supplement, a premarket report, or a premarket notification submission.
The term “premarket report” means a report submitted under section 360e(c)(2) of this title.
The term “premarket notification submission” means a report submitted under section 360(k) of this title.
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—
an application or report has been approved under section 360e(d) of this title, or an application has been approved under section 262 of title 42; or
a notice of completion has become effective under section 360e(f) of this title.
The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness.
The term “180-day supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.
The term “real-time supplement” means a supplement to an approved premarket application or premarket report under section 360e of this title that requests a minor change to the device, such as a minor change to the design of the device, software, 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.
The term “efficacy supplement” means a supplement to an approved premarket application under section 262 of title 42 that requires substantive clinical data.
The term “30-day notice” means a notice under section 360e(d)(5) of this title that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device.
The term “request for classification information” means a request made under section 360c(g) of this title for information respecting the class in which a device has been classified or the requirements applicable to a device.
The term “annual fee”, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order.
The term “de novo classification request” means a request made under section 360c(f)(2)(A) of this title with respect to the classification of a device.
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, premarket notification submissions, and de novo classification requests:
The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions.
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.
The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements.
Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and de novo classification requests.
Review of device applications subject to section 262 of title 42 for an investigational new drug application under section 355(i) of this title or for an investigational device exemption under section 360j(g) of this title and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title.
The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests.
The development of voluntary test methods, consensus standards, or mandatory performance standards under section 360d of this title in connection with the review of such applications, reports, supplements, submissions, or requests and related activities.
The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, submissions, or requests.
Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under section 360e(b) of this title in connection with any requirement for approval of a device.
Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.
Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, premarket notification submissions, or de novo classification requests.
The term “costs of resources allocated for the process for the review of device applications” means the expenses in connection with the process for the review of device applications for—
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;
management of information, and the acquisition, maintenance, and repair of computer resources;
leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and
collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests.
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 October of the preceding fiscal year divided by such Index for October 2021.
The term “person” includes an affiliate thereof.
The term “affiliate” means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly—
one business entity controls, or has the power to control, the other business entity; or
a third party controls, or has power to control, both of the business entities.
The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.
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.
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. § 379i
June 25, 1938, ch. 675, § 737, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1589
Source evidence
Code source credit
June 25, 1938, ch. 675, § 737, as added Pub. L. 107–250, title I, § 102(a), Oct. 26, 2002, 116 Stat. 1589Enacted 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.”.Medical Devices Technical Corrections Act
Pub. L. 108–214 § 2(d)(3)(A) · 118 Stat. 572
Changed · 21 U.S.C. § 379i
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.)”;Medical Devices Technical Corrections Act
Pub. L. 108–214 § 2(a)(1)(A) · 118 Stat. 572
Substituted · 21 U.S.C. § 379i(4)(B)
Pub. L. 108–214, § 2(a)(1)(A), substituted “and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness” for “and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness”
Source evidence
Code amendment note
Par. (4)(B). Pub. L. 108–214, § 2(a)(1)(A), substituted “and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness” for “and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness”.Enacted provision · exact public law section
(A) in paragraph (4)(B), by striking “and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness” and inserting “and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness”;Medical Devices Technical Corrections Act
Pub. L. 108–214 § 2(a)(1)(B) · 118 Stat. 572
Struck · 21 U.S.C. § 379i(4)(D)
Pub. L. 108–214, § 2(a)(1)(B), struck out “manufacturing,” after “software,”
Source evidence
Code amendment note
Par. (4)(D). Pub. L. 108–214, § 2(a)(1)(B), struck out “manufacturing,” after “software,”.Enacted provision · exact public law section
(B) in paragraph (4)(D), by striking “manufacturing,”;Medical Devices Technical Corrections Act
Pub. L. 108–214 § 2(a)(1)(C) · 118 Stat. 572
Substituted · 21 U.S.C. § 379i(5)(J)
Pub. L. 108–214, § 2(a)(1)(C), substituted “a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.” for “a premarket application under section 360e of this title or section 262 of title 42.”
Source evidence
Code amendment note
Par. (5)(J). Pub. L. 108–214, § 2(a)(1)(C), substituted “a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.” for “a premarket application under section 360e of this title or section 262 of title 42.”Enacted provision · exact public law section
(C) in paragraph (5)(J), by striking “a premarket application” and all that follows and inserting “a premarket application or premarket report under section 515 or a premarket application under section 351 of the Public Health Service Act.”; andMedical Devices Technical Corrections Act
Pub. L. 108–214 § 2(a)(1)(D) · 118 Stat. 572
Substituted · 21 U.S.C. § 379i(8)
Pub. L. 108–214, § 2(a)(1)(D), substituted “The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)” for “The term ‘affiliate’ means a business entity that has a relationship with a second business entity”
Source evidence
Code amendment note
Par. (8). Pub. L. 108–214, § 2(a)(1)(D), substituted “The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)” for “The term ‘affiliate’ means a business entity that has a relationship with a second business entity”.Enacted provision · exact public law section
(D) in paragraph (8), by striking “The term ‘affiliate’ means a business entity that has a relationship with a second business entity” and inserting “The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)”; andMedical Device User Fee Amendments of 2007
Pub. L. 110–85 § 211(1) · 121 Stat. 823
Substituted · 21 U.S.C. § 379i
Pub. L. 110–85, § 211(1), substituted “For purposes of this subpart” for “For purposes of this part” in introductory provisions
Source evidence
Code amendment note
Pub. L. 110–85, § 211(1), substituted “For purposes of this subpart” for “For purposes of this part” in introductory provisions.Enacted provision · exact public law section
(1) in the matter preceding paragraph (1), by striking “For purposes of this subchapter” and inserting “For purposes of this part”;Medical Device User Fee Amendments of 2007
Pub. L. 110–85 § 211(2) · 121 Stat. 823
Added · 21 U.S.C. § 379i(5)(9)
Pub. L. 110–85, § 211(2), (3), added pars. (5) to (7)
Redesignated · 21 U.S.C. § 379i(5)(9)
Pub. L. 110–85, § 211(2), (3), redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively
Source evidence
Code amendment note
Pars. (5) to (9). Pub. L. 110–85, § 211(2), (3), added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively.Enacted provision · exact public law section
(2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively;Medical Device User Fee Amendments of 2007
Pub. L. 110–85 § 211(2) · 121 Stat. 823
Redesignated · 21 U.S.C. § 379i(10)
Pub. L. 110–85, § 211(2), (4), redesignated par. (7) as (10)
Substituted · 21 U.S.C. § 379i(10)
Pub. L. 110–85, § 211(2), (4), substituted “October of the preceding fiscal year” for “April of the preceding fiscal year”
Substituted · 21 U.S.C. § 379i(10)
Pub. L. 110–85, § 211(2), (4), substituted “October 2001” for “April 2002”
Source evidence
Code amendment note
Par. (10). Pub. L. 110–85, § 211(2), (4), redesignated par. (7) as (10) and substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 2001” for “April 2002”.Enacted provision · exact public law section
(2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively;Medical Device User Fee Amendments of 2007
Pub. L. 110–85 § 211(5) · 121 Stat. 823
Added · 21 U.S.C. § 379i(11)
Pub. L. 110–85, § 211(5), added par. (11)
Source evidence
Code amendment note
Par. (11). Pub. L. 110–85, § 211(5), added par. (11).Enacted provision · exact public law section
(5) by inserting after paragraph (10), as so amended, the following: “(11) The term ‘person’ includes an affiliate thereof.” ; andMedical Device User Fee Amendments of 2007
Pub. L. 110–85 § 211(2) · 121 Stat. 823
Redesignated · 21 U.S.C. § 379i(12)
Pub. L. 110–85, § 211(2), redesignated par. (8) as (12)
Source evidence
Code amendment note
Par. (12). Pub. L. 110–85, § 211(2), redesignated par. (8) as (12).Enacted provision · exact public law section
(2) by redesignating paragraphs (5), (6), (7), and (8) as paragraphs (8), (9), (10), and (12), respectively;Medical Device User Fee Amendments of 2007
Pub. L. 110–85 § 211(6) · 121 Stat. 823
Added · 21 U.S.C. § 379i(13)
Pub. L. 110–85, § 211(6), added par. (13)
Source evidence
Code amendment note
Par. (13). Pub. L. 110–85, § 211(6), added par. (13).Enacted provision · exact public law section
(6) by inserting after paragraph (12), as so redesignated, the following: “(13) The term ‘establishment subject to a registration fee’ means an establishment that is required to register with the Secretary under section 510 and is one of the following types of establishments: “(A) Manufacturer.— An establishment that makes by any means any article that is a device, including an establishment that sterilizes or otherwise makes such article for or on behalf of a specification developer or any other person. “(B) Single-use device reprocessor.— An establishment that, within the meaning of section 201(ll)(2)(A), performs additional processing and manufacturing operations on a single-use device that has previously been used on a patient. “(C) Specification developer.— An establishment that develops specifications for a device that is distributed under the establishment’s name but which performs no manufacturing, including an establishment that, in addition to developing specifications, also arranges for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.” .Medical Device User Fee Amendments of 2012
Pub. L. 112–144 § 202(1) · 126 Stat. 993
Struck · 21 U.S.C. § 379i(9)
Pub. L. 112–144, § 202(1), struck out “incurred” after “expenses” in introductory provisions
Source evidence
Code amendment note
Par. (9). Pub. L. 112–144, § 202(1), struck out “incurred” after “expenses” in introductory provisions.Enacted provision · exact public law section
(1) in paragraph (9), by striking “incurred” after “expenses”;Medical Device User Fee Amendments of 2012
Pub. L. 112–144 § 202(2) · 126 Stat. 993
Substituted · 21 U.S.C. § 379i(10)
Pub. L. 112–144, § 202(2), substituted “October 2011” for “October 2001”
Source evidence
Code amendment note
Par. (10). Pub. L. 112–144, § 202(2), substituted “October 2011” for “October 2001”.Enacted provision · exact public law section
(2) in paragraph (10), by striking “October 2001” and inserting “October 2011”; andMedical Device User Fee Amendments of 2012
Pub. L. 112–144 § 202(3) · 126 Stat. 993
Substituted · 21 U.S.C. § 379i(13)
Pub. L. 112–144, § 202(3), substituted “is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.” for “is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:”
Struck · 21 U.S.C. § 379i(13)
Pub. L. 112–144, § 202(3), struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments
Source evidence
Code amendment note
Par. (13). Pub. L. 112–144, § 202(3), substituted “is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.” for “is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:” and struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments.Enacted provision · exact public law section
(3) in paragraph (13), by striking “is required to register” and all that follows through the end of paragraph (13) and inserting the following: “is registered (or is required to register) with the Secretary under section 510 because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.”.21st Century Cures Act
Pub. L. 114–255 div. A title III § 3051(c)(2) · 130 Stat. 1033
Substituted · 21 U.S.C. § 379i(5)
Pub. L. 114–255 substituted “360e(d)(5)” for “360e(d)(6)”
Source evidence
Code amendment note
Par. (5). Pub. L. 114–255 substituted “360e(d)(5)” for “360e(d)(6)”.Enacted provision · exact public law section
(2) Conforming amendment.— Section 737(5) of the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 379i(5)) is amended by striking “515(d)(6)” and inserting “515(d)(5)”.Medical Device User Fee Amendments of 2017
Pub. L. 115–52 § 202(a)(2) · 131 Stat. 1005
Redesignated · 21 U.S.C. § 379i(8)
Pub. L. 115–52, § 202(a)(2), added par. (8). Former par. (8) redesignated (9)
Source evidence
Code amendment note
Par. (8). Pub. L. 115–52, § 202(a)(2), added par. (8). Former par. (8) redesignated (9).Enacted provision · exact public law section
(2) by inserting after paragraph (7) the following new paragraph: “(8) The term ‘de novo classification request’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.” ;Medical Device User Fee Amendments of 2017
Pub. L. 115–52 § 202(a)(1) · 131 Stat. 1005
Redesignated · 21 U.S.C. § 379i(9)
Pub. L. 115–52, § 202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10)
Source evidence
Code amendment note
Par. (9). Pub. L. 115–52, § 202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10).Enacted provision · exact public law section
(1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;Medical Device User Fee Amendments of 2017
Pub. L. 115–52 § 202(a)(1) · 131 Stat. 1005
Redesignated · 21 U.S.C. § 379i(10)
Pub. L. 115–52, § 202(a)(1), (3), redesignated par. (9) as (10)
Redesignated · 21 U.S.C. § 379i(10)
Pub. L. 115–52, § 202(a)(1), (3), substituted “submissions, and de novo classification requests” for “and submissions” in subpar. (D). Former par. (10) redesignated (11)
Source evidence
Code amendment note
Par. (10). Pub. L. 115–52, § 202(a)(1), (3), redesignated par. (9) as (10) and substituted “submissions, and de novo classification requests” for “and submissions” in subpar. (D). Former par. (10) redesignated (11).Enacted provision · exact public law section
(1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;Medical Device User Fee Amendments of 2017
Pub. L. 115–52 § 202(a)(1) · 131 Stat. 1005
Redesignated · 21 U.S.C. § 379i(11)
Pub. L. 115–52, § 202(a)(1), (4), redesignated par. (10) as (11)
Substituted · 21 U.S.C. § 379i(11)
Pub. L. 115–52, § 202(a)(1), (4), substituted “2016” for “2011”
Source evidence
Code amendment note
Par. (11). Pub. L. 115–52, § 202(a)(1), (4), redesignated par. (10) as (11) and substituted “2016” for “2011”.Enacted provision · exact public law section
(1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;Medical Device User Fee Amendments of 2017
Pub. L. 115–52 § 202(a)(1) · 131 Stat. 1005
Redesignated · 21 U.S.C. § 379i(12)(14)
Pub. L. 115–52, § 202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively
Source evidence
Code amendment note
Pars. (12) to (14). Pub. L. 115–52, § 202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively.Enacted provision · exact public law section
(1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;Medical Device User Fee Amendments of 2022
Pub. L. 117–180 § 2002(1)(A) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379i(9)
Pub. L. 117–180, § 2002(1)(A), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions” in introductory provisions
Source evidence
Code amendment note
Par. (9). Pub. L. 117–180, § 2002(1)(A), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions” in introductory provisions.Enacted provision · exact public law section
(A) in the matter preceding subparagraph (A), by striking “and premarket notification submissions” and inserting “premarket notification submissions, and de novo classification requests”;Effective date note
Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title 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.Medical Device User Fee Amendments of 2022
Pub. L. 117–180 § 2002(1)(B) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379i(9)(D)
Pub. L. 117–180, § 2002(1)(B), substituted “submissions, and de novo classification requests” for “and submissions”
Source evidence
Code amendment note
Par. (9)(D). Pub. L. 117–180, § 2002(1)(B), substituted “submissions, and de novo classification requests” for “and submissions”.Enacted provision · exact public law section
(B) in subparagraph (D), by striking “and submissions” and inserting “submissions, and de novo classification requests”;Effective date note
Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title 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.Medical Device User Fee Amendments of 2022
Pub. L. 117–180 § 2002(1)(C) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379i(9)(F)
Pub. L. 117–180, § 2002(1)(C), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions”
Source evidence
Code amendment note
Par. (9)(F). Pub. L. 117–180, § 2002(1)(C), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions”.Enacted provision · exact public law section
(C) in subparagraph (F), by striking “and premarket notification submissions” and inserting “premarket notification submissions, and de novo classification requests”;Effective date note
Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title 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.Medical Device User Fee Amendments of 2022
Pub. L. 117–180 § 2002(1)(D) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379i(9)(G); 21 U.S.C. § 379i(9)(H)
Pub. L. 117–180, § 2002(1)(D), substituted “submissions, or requests” for “or submissions”
Source evidence
Code amendment note
Par. (9)(G), (H). Pub. L. 117–180, § 2002(1)(D), substituted “submissions, or requests” for “or submissions”.Enacted provision · exact public law section
(D) in each of subparagraphs (G) and (H), by striking “or submissions” and inserting “submissions, or requests”; andEffective date note
Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title 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.Medical Device User Fee Amendments of 2022
Pub. L. 117–180 § 2002(1)(E) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379i(9)(K)
Pub. L. 117–180, § 2002(1)(E), substituted “premarket notification submissions, or de novo classification requests” for “or premarket notification submissions”
Source evidence
Code amendment note
Par. (9)(K). Pub. L. 117–180, § 2002(1)(E), substituted “premarket notification submissions, or de novo classification requests” for “or premarket notification submissions”.Enacted provision · exact public law section
(E) in subparagraph (K), by striking “or premarket notification submissions” and inserting “premarket notification submissions, or de novo classification requests”; andEffective date note
Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title 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.Medical Device User Fee Amendments of 2022
Pub. L. 117–180 § 2002(2) · 136 Stat. 2114
Substituted · 21 U.S.C. § 379i(11)
Pub. L. 117–180, § 2002(2), substituted “2021” for “2016”
Source evidence
Code amendment note
Par. (11). Pub. L. 117–180, § 2002(2), substituted “2021” for “2016”.Enacted provision · exact public law section
(2) in paragraph (11), by striking “2016” and inserting “2021”.Effective date note
Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title 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.
33 of 33 references resolved to an enrolled provision
Notes
Termination of Section
For termination of section by section 2007(a) of Pub. L. 117–180, see Effective and Termination Dates note below.
Editorial Notes
Amendments2004–2022 · 6 rounds
2022
Par. (9). Pub. L. 117–180, § 2002(1)(A), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions” in introductory provisions.
Par. (9)(D). Pub. L. 117–180, § 2002(1)(B), substituted “submissions, and de novo classification requests” for “and submissions”.
Par. (9)(F). Pub. L. 117–180, § 2002(1)(C), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions”.
Par. (9)(G), (H). Pub. L. 117–180, § 2002(1)(D), substituted “submissions, or requests” for “or submissions”.
Par. (9)(K). Pub. L. 117–180, § 2002(1)(E), substituted “premarket notification submissions, or de novo classification requests” for “or premarket notification submissions”.
Par. (11). Pub. L. 117–180, § 2002(2), substituted “2021” for “2016”.
2017
Par. (8). Pub. L. 115–52, § 202(a)(2), added par. (8). Former par. (8) redesignated (9).
Par. (9). Pub. L. 115–52, § 202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10).
Par. (10). Pub. L. 115–52, § 202(a)(1), (3), redesignated par. (9) as (10) and substituted “submissions, and de novo classification requests” for “and submissions” in subpar. (D). Former par. (10) redesignated (11).
Par. (11). Pub. L. 115–52, § 202(a)(1), (4), redesignated par. (10) as (11) and substituted “2016” for “2011”.
Pars. (12) to (14). Pub. L. 115–52, § 202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively.
2016
Par. (5). Pub. L. 114–255 substituted “360e(d)(5)” for “360e(d)(6)”.
2012
Par. (9). Pub. L. 112–144, § 202(1), struck out “incurred” after “expenses” in introductory provisions.
Par. (10). Pub. L. 112–144, § 202(2), substituted “October 2011” for “October 2001”.
Par. (13). Pub. L. 112–144, § 202(3), substituted “is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.” for “is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:” and struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments.
2007
Pub. L. 110–85, § 211(1), substituted “For purposes of this subpart” for “For purposes of this part” in introductory provisions.
Pars. (5) to (9). Pub. L. 110–85, § 211(2), (3), added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively.
Par. (10). Pub. L. 110–85, § 211(2), (4), redesignated par. (7) as (10) and substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 2001” for “April 2002”.
Par. (11). Pub. L. 110–85, § 211(5), added par. (11).
Par. (12). Pub. L. 110–85, § 211(2), redesignated par. (8) as (12).
Par. (13). Pub. L. 110–85, § 211(6), added par. (13).
2004
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.
Par. (4)(B). Pub. L. 108–214, § 2(a)(1)(A), substituted “and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness” for “and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness”.
Par. (4)(D). Pub. L. 108–214, § 2(a)(1)(B), struck out “manufacturing,” after “software,”.
Par. (5)(J). Pub. L. 108–214, § 2(a)(1)(C), substituted “a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.” for “a premarket application under section 360e of this title or section 262 of title 42.”
Par. (8). Pub. L. 108–214, § 2(a)(1)(D), substituted “The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)” for “The term ‘affiliate’ means a business entity that has a relationship with a second business entity”.
Statutory Notes and Related Subsidiaries
Effective Date of 2022 Amendment
Amendment by Pub. L. 117–180 effective , with fees under this subpart to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after , see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.
Effective Date of 2017 Amendment
Pub. L. 115–52, title II, § 209, , 131 Stat. 1020, provided that: “The amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after , regardless of the date of the enactment of this Act.”
Effective Date of 2012 Amendment
Pub. L. 112–144, title II, § 206, , 126 Stat. 1007, provided that: “The amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] received on or after , regardless of the date of the enactment of this Act.”
Effective and Termination Dates of 2007 Amendment
Pub. L. 110–85, title II, § 216, , 121 Stat. 852, provided that: “The amendments made by this subtitle [subtitle A (§§ 211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title] shall take effect on , or the date of the enactment of this Act [], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all premarket applications, premarket reports, supplements, 30-day notices, and premarket notification submissions received on or after , regardless of the date of the enactment of this Act.”
Pub. L. 110–85, title II, § 217, , 121 Stat. 852, which provided that the amendments by sections 211 to 217 of Pub. L. 110–85 (amending this section and section 379j of this title) would cease to be effective , and that section 379j–1 of this title would cease to be effective , was repealed by Pub. L. 112–144, title II, § 207(b)(1), , 126 Stat. 1007.
Effective and Termination Dates
Pub. L. 117–180, div. F, title II, § 2007(a), , 136 Stat. 2154, provided that: “Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) shall cease to be effective .”
Pub. L. 115–52, title II, § 210(a), , 131 Stat. 1020, which provided that this section and section 379j of this title would cease to be effective , was repealed by Pub. L. 117–180, div. F, title II, § 2007(c), , 136 Stat. 2154.
[Pub. L. 117–180, div. F, title II, § 2007(c), , 136 Stat. 2154, provided that the repeal of section 210(a) of Pub. L. 115–52, formerly set out above, is effective .]
Pub. L. 112–144, title II, § 207(a), , 126 Stat. 1007, which provided that sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) would cease to be effective , and that section 738A (21 U.S.C. 379j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) would cease to be effective , was repealed by Pub. L. 115–52, title II, § 210(c), , 131 Stat. 1020.
[Pub. L. 115–52, title II, § 210(c), , 131 Stat. 1020, provided that the repeal of section 207(a) of Pub. L. 112–144, formerly set out above, is effective .]
Pub. L. 107–250, title I, § 106, , 116 Stat. 1602, provided that: “The amendments made by this title [enacting this subpart] shall take effect on the date of the enactment of this Act [], except that fees shall be assessed for all premarket applications, premarket reports, supplements, and premarket notification submissions received on or after , regardless of the date of enactment.”
Pub. L. 107–250, title I, § 107, , 116 Stat. 1602, which provided that the amendments made by title I of Pub. L. 107–250 (enacting this subpart) would cease to be effective , except that section 103 of Pub. L. 107–250, set out as a note below, would cease to be effective , was repealed by Pub. L. 112–144, title II, § 207(c)(1), , 126 Stat. 1007.
[Pub. L. 112–144, title II, § 207(c), , 126 Stat. 1007, provided that the repeal of section 107 of Pub. L. 107–250, formerly set out above, is effective .]
Savings Provisions
Pub. L. 117–180, div. F, title II, § 2009, , 136 Stat. 2155, provided that: “Notwithstanding the amendments made by this title [amending this section and sections 379j and 379j–1 of this title and repealing provisions set out as notes under this section and section 379j–1 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after , but before , were received by the Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.”
Pub. L. 115–52, title II, § 208, , 131 Stat. 1019, provided that: “Notwithstanding the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after , but before , were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.”
Pub. L. 112–144, title II, § 205, , 126 Stat. 1007, provided that: “Notwithstanding the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title [], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [21 U.S.C. 379j(a)(2)(A)] (in effect as of such day) that on or after , but before , were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2013.”
Pub. L. 110–85, title II, § 214, , 121 Stat. 852, provided that: “Notwithstanding section 107 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) [formerly set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§ 211–217) of title II of Pub. L. 110–85, enacting section 379j–1 of this title and amending this section and section 379j of this title], part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this subtitle [], shall continue to be in effect with respect to premarket applications, premarket reports, premarket notification submissions, and supplements (as defined in such part as of such day) that on or after , but before , were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2008.”
Congressional Findings Concerning Fees Relating to Devices
Pub. L. 117–180, div. F, title II, § 2001(b), , 136 Stat. 2147, provided that: “Congress finds that the fees authorized under the amendments made by this title [amending this section and sections 379j and 379j–1 of this title and repealing provisions set out as notes under this section and section 379j–1 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 115–52, title II, § 201(b), , 131 Stat. 1013, provided that: “The Congress finds that the fees authorized under the amendments made by this title [see section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under section 301 of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 112–144, title II, § 201(b), , 126 Stat. 1002, provided that: “The Congress finds that the fees authorized under the amendments made by this title [enacting section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 110–85, title II, § 201(c), , 121 Stat. 842, provided that: “The Congress finds that the fees authorized under the amendments made by this title [enacting section 379j–1 of this title and amending this section and sections 333, 360, 360i, 360m, 374, and 379j of this title] will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i et seq.] in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.”
Pub. L. 107–250, title I, § 101, , 116 Stat. 1589, provided that:
“The Congress finds that—
“(1) prompt approval and clearance of safe and effective devices is critical to the improvement of the public health so that patients may enjoy the benefits of devices to diagnose, treat, and prevent disease;
“(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of devices and the assurance of device safety and effectiveness so that statutorily mandated deadlines may be met; and
“(3) the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and section 379j of this title] will be dedicated to meeting the goals identified in the letters from the Secretary of Health and Human Services to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record.”
Annual Reports
Pub. L. 107–250, title I, § 103, , 116 Stat. 1600, as amended by Pub. L. 109–43, § 2(b), , 119 Stat. 441, provided that:
“(a) In General.—
Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning—
“(1) the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of Pub. L. 107–250 does not contain parts]; and
“(2) the implementation of the authority for such fees during such fiscal year, and the use, by the Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical device user-fee program established under the amendment made by section 102 [enacting this subpart].
“(b) Additional Information.—
For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—
“(1) information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and
“(2) a certification by the Secretary that the amounts appropriated for salaries and expenses of the Food and Drug Administration for such fiscal year and obligated by the Secretary for the performance of any function relating to devices that is not for the process for the review of device applications, as defined in paragraph (5) [now (8)] of section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than such amounts for fiscal year 2002 multiplied by the adjustment factor, as defined in paragraph (7) [now (10)] of such section 737.”
Study
Pub. L. 107–250, title I, § 104(b), , 116 Stat. 1601, directed the Secretary of Health and Human Services to conduct a study for the purpose of making certain determinations regarding the medical device user-fee program established under the amendment made by section 102 of Pub. L. 107–250 and to submit a report to Congress by .
Consultation
Pub. L. 107–250, title I, § 105, , 116 Stat. 1601, provided that:
“(a) In General.—
In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of medical device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379i, 379j], the Secretary of Health and Human Services (referred to in this section as the ‘Secretary’) shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.
“(b) Recommendations.—
The Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.”
Credits
1938–2022 · 7 acts
- 1938June 25, 1938, ch. 675, § 737, as added Pub. L. 107–250, title I, § 102(a), , 116 Stat. 1589
- 2004amended Pub. L. 108–214, § 2(a)(1), (d)(3)(A), , 118 Stat. 572, 577
- 2007Pub. L. 110–85, title II, § 211, , 121 Stat. 843
- 2012Pub. L. 112–144, title II, § 202, , 126 Stat. 1002
- 2016Pub. L. 114–255, div. A, title III, § 3051(c)(2), , 130 Stat. 1124
- 2017Pub. L. 115–52, title II, § 202(a), , 131 Stat. 1013
- 2022Pub. L. 117–180, div. F, title II, § 2002, , 136 Stat. 2148.
Show as published
(June 25, 1938, ch. 675, § 737, as added Pub. L. 107–250, title I, § 102(a), , 116 Stat. 1589; amended Pub. L. 108–214, § 2(a)(1), (d)(3)(A), , 118 Stat. 572, 577; Pub. L. 110–85, title II, § 211, , 121 Stat. 843; Pub. L. 112–144, title II, § 202, , 126 Stat. 1002; Pub. L. 114–255, div. A, title III, § 3051(c)(2), , 130 Stat. 1124; Pub. L. 115–52, title II, § 202(a), , 131 Stat. 1013; Pub. L. 117–180, div. F, title II, § 2002, , 136 Stat. 2148.)