§ 360m. Accredited persons

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

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 title II § 210(a) · 111 Stat. 2296

   Enacted · 21 U.S.C. § 360m

   June 25, 1938, ch. 675, § 523, as added Pub. L. 105–115, title II, § 210(a), Nov. 21, 1997, 111 Stat. 2342

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 523, as added Pub. L. 105–115, title II, § 210(a), Nov. 21, 1997, 111 Stat. 2342

   Enacted provision · exact public law section
   (a) In General.— Subchapter A of chapter V is amended by adding at the end the following: “SEC. 523. ACCREDITED PERSONS. “(a) In General.— “(1) Review and classification of devices.— Not later than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under section 510(k) and making recommendations to the Secretary regarding the initial classification of devices under section 513(f)(1). “(2) Requirements regarding review.— “(A) In general.— In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation. “(B) Time period for review.— Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. “(C) Special rule.— The Secretary may change the initial classification under section 513(f)(1) that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under section 510(k) for the device, a statement explaining in detail the reasons for the change. “(3) Certain devices.— “(A) In general.— An accredited person may not be used to perform a review of— “(i) a class III device; “(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or “(iii) a class II device which requires clinical data in the report submitted under section 510(k) for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year. “(B) Adjustment.— In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 510(k) were not required to be submitted by reason of the operation of section 510(m). “(b) Accreditation.— “(1) Programs.— The Secretary shall provide for such accreditation through programs administered by the Food and Drug Administration, other government agencies, or by other qualified nongovernment organizations. “(2) Accreditation.— “(A) In general.— Not later than 180 days after the Federal Register, publication. date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall establish and publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in subsection (a). The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The accreditation of such person shall specify the particular activities under subsection (a) for which such person is accredited. “(B) Withdrawal of accreditation.— The Secretary may suspend or withdraw accreditation of any person accredited under this paragraph, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this section. “(C) Performance auditing.— To ensure that persons accredited under this section will continue to meet the standards of accreditation, the Secretary shall— “(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such person; and “(ii) take such additional measures as the Secretary determines to be appropriate. “(D) Annual report.— The Secretary shall include in the annual report required under section 903(g) the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year. “(3) Qualifications.— An accredited person shall, at a minimum, meet the following requirements: “(A) Such person may not be an employee of the Federal Government. “(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of devices and which has no organizational, material, or financial affiliation with such a manufacturer, supplier, or vendor. “(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation. “(D) Such person shall not engage in the design, manufacture, promotion, or sale of devices. “(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices and shall agree in writing that as a minimum it will— “(i) certify that reported information accurately reflects data reviewed; “(ii) limit work to that for which competence and capacity are available; “(iii) treat information received, records, reports, and recommendations as proprietary information; “(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and “(v) protect against the use, in carrying out subsection (a) with respect to a device, of any officer or employee of the person who has a financial conflict of interest regarding the device, and annually make available to the public disclosures of the extent to which the person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest. “(4) Selection of accredited persons.—The Secretary shall provide each person who chooses to use an accredited person to receive a section 510(k) report a panel of at least two or more accredited persons from which the regulated person may select one for a specific regulatory function. “(5) Compensation of accredited persons.— Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services. “(c) Duration.— The authority provided by this section terminates— “(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review at least 60 percent of the submissions under section 510(k), or “(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a determination described in paragraph (2)(B) of subsection (a) for at least 35 percent of the devices that are subject to review under paragraph (1) of such subsection, whichever occurs first.”.

2. 2002

   Medical Device User Fee and Modernization Act of 2002

   Pub. L. 107–250 § 202(1) · 116 Stat. 1588

   Substituted · 21 U.S.C. § 360m(c)

   Pub. L. 107–250, § 202(1), substituted “The authority provided by this section terminates October 1, 2007.” for “The authority provided by this section terminates—

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 107–250, § 202(1), substituted “The authority provided by this section terminates October 1, 2007.” for “The authority provided by this section terminates—

   “(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) of this section are available to review at least 60 percent of the submissions under section 360(k) of this title, or “(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a determination described in paragraph (2)(B) of subsection (a) of this section for at least 35 percent of the devices that are subject to review under paragraph (1) of such subsection, whichever occurs first.”

   Enacted provision · exact public law section
   (1) in subsection (c), by striking “The authority” and all that follows and inserting the following: “The authority provided by this section terminates October 1, 2007.”; and

3. 2002

   Medical Device User Fee and Modernization Act of 2002

   Pub. L. 107–250 § 202(2) · 116 Stat. 1588

   Added · 21 U.S.C. § 360m(d)

   Pub. L. 107–250, § 202(2), added subsec. (d)

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 107–250, § 202(2), added subsec. (d).

   Enacted provision · exact public law section
   (2) by adding at the end the following subsection: Not later than January 10, 2007, the Secretary shall conduct a study based on the experience under the program under this section and submit to the Committee on Energy and Deadline. Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the findings of the study. The objectives of the study shall include determining— “(1) the number of devices reviewed under this section; “(2) the number of devices reviewed under this section that were ultimately cleared by the Secretary; “(3) the number of devices reviewed under this section that were ultimately not cleared by the Secretary; “(4) the average time period for a review under this section (including the time it takes for the Secretary to review a recommendation of an accredited person under subsection (a) and determine the initial device classification); “(5) the average time period identified in paragraph (4) compared to the average time period for review of devices solely by the Secretary pursuant to section 510(k); “(6) if there is a difference in the average time period under paragraph (4) and the average time period under paragraph (5), the reasons for such difference; “(7) whether the quality of reviews under this section for devices for which no guidance has been issued is qualitatively inferior to reviews by the Secretary for devices for which no guidance has been issued; “(8) whether the quality of reviews under this section of devices for which no guidance has been issued is qualitatively inferior to reviews under this section of devices for which guidance has been issued; “(9) whether this section has in any way jeopardized or improved the public health; “(10) any impact of this section on resources available to the Secretary to review reports under section 510(k); and “(11) any suggestions for continuation, modification (including contraction or expansion of device eligibility), or termination of this section that the Secretary determines to be appropriate.”.

4. 2007

   Medical Device User Fee Amendments of 2007

   Pub. L. 110–85 title II § 221 · 121 Stat. 823

   Substituted · 21 U.S.C. § 360m(c)

   Pub. L. 110–85 substituted “2012” for “2007”

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 110–85 substituted “2012” for “2007”.

   Enacted provision · exact public law section
   SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET NOTIFICATION.   Section 523(c) (21 U.S.C. 360m(c)) is amended by striking “2007” and inserting “2012”.

5. 2009

   Family Smoking Prevention and Tobacco Control Act

   Pub. L. 111–31 div. A title I § 103(f) · 123 Stat. 1776

   Changed · 21 U.S.C. § 360m(b)(2)(D)

   Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title

   Source evidence

   Code amendment note
   Subsec. (b)(2)(D). Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.

   Enacted provision · exact public law section
   (f) Section 523.— Section 523(b)(2)(D) (21 U.S.C. 360m(b)(2)(D)) is amended by striking “section 903(g)” and inserting “section 1003(g)”.

6. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 611(a) · 126 Stat. 993

   Added · 21 U.S.C. § 360m(b)(2)(E)

   Pub. L. 112–144, § 611(a), added subpar. (E)

   Source evidence

   Code amendment note
   Subsec. (b)(2)(E). Pub. L. 112–144, § 611(a), added subpar. (E).

   Enacted provision · exact public law section
   (a) Periodic Reaccreditation.— Section 523(b)(2) (21 U.S.C. 360m(b)(2)) is amended by adding at the end of the following: “(E) Periodic reaccreditation.— Deadlines. “(i) Period.— Subject to suspension or withdrawal under subparagraph (B), any accreditation under this section shall be valid for a period of 3 years after its issuance. “(ii) Response to reaccreditation request.— Upon the submission of a request by an accredited person for reaccreditation under this section, the Secretary shall approve or deny such request not later than 60 days after receipt of the request. “(iii) Criteria.— Not later than 120 days after the date of the enactment of this subparagraph, the Secretary shall establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation to persons under this section. The reaccreditation of persons under this section shall specify the particular activities under subsection (a), and the devices, for which such persons are reaccredited.” .

7. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 611(b) · 126 Stat. 993

   Substituted · 21 U.S.C. § 360m(c)

   Pub. L. 112–144, § 611(b), substituted “October 1, 2017” for “October 1, 2012”

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 112–144, § 611(b), substituted “October 1, 2017” for “October 1, 2012”.

   Enacted provision · exact public law section
   (b) Duration of Authority.— Section 523(c) (21 U.S.C. 360m(c)) is amended by striking “October 1, 2012” and inserting “October 1, 2017”.

8. 2016

   21st Century Cures Act

   Pub. L. 114–255 div. A title III § 3102(4) · 130 Stat. 1033

   Struck · 21 U.S.C. § 360m(d)

   Pub. L. 114–255 struck out subsec. (d) which related to report to Congress

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 114–255 struck out subsec. (d) which related to report to Congress.

   Enacted provision · exact public law section
   (4) in section 523 (21 U.S.C. 360m), by striking subsection (d).

9. 2017

   Medical Device User Fee Amendments of 2017

   Pub. L. 115–52 § 206(1)(A) · 131 Stat. 1005

   1. Added · 21 U.S.C. § 360m(a)(3)(A)(ii)(iv)

      Pub. L. 115–52, § 206(1)(A), added cls. (ii) to (iv)

   2. Struck · 21 U.S.C. § 360m(a)(3)(A)(ii)(iv)

      Pub. L. 115–52, § 206(1)(A), struck out former cls. (ii) and (iii) which read as follows:

   Source evidence

   Code amendment note
   Subsec. (a)(3)(A)(ii) to (iv). Pub. L. 115–52, § 206(1)(A), added cls. (ii) to (iv) and struck out former cls. (ii) and (iii) which read as follows:

   “(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or “(iii) a class II device which requires clinical data in the report submitted under section 360(k) of this title for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year.”

   Enacted provision · exact public law section
   (A) in subparagraph (A), by striking clauses (ii) and (iii) and inserting the following: “(ii) a device classified under section 513(f)(2) or designated under section 515C(d); “(iii) a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)(iii); or “(iv) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).” ;

10. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 206(1)(B) · 131 Stat. 1005

    1. Added · 21 U.S.C. § 360m(a)(3)(B)

       Pub. L. 115–52, § 206(1)(B), added subpar. (B)

    2. Struck · 21 U.S.C. § 360m(a)(3)(B)

       Pub. L. 115–52, § 206(1)(B), struck out former subpar. (B). Prior to amendment, text read as follows: “In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 360(k) of this title were not required to be submitted by reason of the operation of section 360(m) of this title.”

    Source evidence

    Code amendment note
    Subsec. (a)(3)(B). Pub. L. 115–52, § 206(1)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: “In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 360(k) of this title were not required to be submitted by reason of the operation of section 360(m) of this title.”

    Enacted provision · exact public law section
    (B) by striking subparagraph (B) and inserting the following: “(B) Designation for review.— The Secretary shall— “(i) issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including— “(I) the risk of the device type, or subset of such device type; and “(II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset; “(ii) not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and “(iii) beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary’s determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).” ; and

11. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 206(1)(C) · 131 Stat. 1005

    Added · 21 U.S.C. § 360m(a)(3)(C)

    Pub. L. 115–52, § 206(1)(C), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (a)(3)(C). Pub. L. 115–52, § 206(1)(C), added subpar. (C).

    Enacted provision · exact public law section
    (C) by adding at the end the following: “(C) Interim rule.— Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on the date of enactment the Medical Device User Fee Amendments of 2017 shall be in effect.” ;

12. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 206(2)(A) · 131 Stat. 1005

    1. Redesignated · 21 U.S.C. § 360m(b)(2)(D); 21 U.S.C. § 360m(b)(2)(E)

       Pub. L. 115–52, § 206(2)(A), redesignated subpar. (E) as (D)

    2. Struck · 21 U.S.C. § 360m(b)(2)(D); 21 U.S.C. § 360m(b)(2)(E)

       Pub. L. 115–52, § 206(2)(A), struck out former subpar. (D). Prior to amendment, text of subpar. (D) read as follows: “The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year.”

    Source evidence

    Code amendment note
    Subsec. (b)(2)(D), (E). Pub. L. 115–52, § 206(2)(A), redesignated subpar. (E) as (D) and struck out former subpar. (D). Prior to amendment, text of subpar. (D) read as follows: “The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year.”

    Enacted provision · exact public law section
    (A) in paragraph (2)— (i) by striking subparagraph (D); and (ii) by redesignating subparagraph (E) as subparagraph (D); and

13. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 206(2)(B)(iii) · 131 Stat. 1005

    Redesignated · 21 U.S.C. § 360m(b)(3)(E)

    Pub. L. 115–52, § 206(2)(B)(iii), added subpar. (E). Former subpar. (E) redesignated (F)

    Source evidence

    Code amendment note
    Subsec. (b)(3)(E). Pub. L. 115–52, § 206(2)(B)(iii), added subpar. (E). Former subpar. (E) redesignated (F).

    Enacted provision · exact public law section
    (iii) by inserting after subparagraph (D) the following new subparagraph: “(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.” ; and

14. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 206(2)(B)(i) · 131 Stat. 1005

    1. Redesignated · 21 U.S.C. § 360m(b)(3)(F)

       Pub. L. 115–52, § 206(2)(B)(i), (ii), redesignated subpar. (E) as (F)

    2. Substituted · 21 U.S.C. § 360m(b)(3)(F)

       Pub. L. 115–52, § 206(2)(B)(i), (ii), substituted “Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section” for “The operations of such person shall be in accordance with generally accepted professional and ethical business practices and shall agree in writing that as a minimum it will” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (b)(3)(F). Pub. L. 115–52, § 206(2)(B)(i), (ii), redesignated subpar. (E) as (F) and substituted “Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section” for “The operations of such person shall be in accordance with generally accepted professional and ethical business practices and shall agree in writing that as a minimum it will” in introductory provisions.

    Enacted provision · exact public law section
    (i) by redesignating subparagraph (E) as subparagraph (F);

15. 2017

    Medical Device User Fee Amendments of 2017

    Pub. L. 115–52 § 206(3) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 360m(c)

    Pub. L. 115–52, § 206(3), substituted “2022’ for “2017”

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 115–52, § 206(3), substituted “2022’ for “2017”.

    Enacted provision · exact public law section
    (3) in subsection (c), by striking “2017” and inserting “2022”.

16. 2022

    Medical Device User Fee Amendments of 2022

    Pub. L. 117–180 div. F title II § 2006 · 136 Stat. 2114

    Substituted · 21 U.S.C. § 360m(c)

    Pub. L. 117–180 substituted “December 17” for “October 1”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–180 substituted “December 17” for “October 1”.

    Enacted provision · exact public law section
    SEC. 2006. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.   Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “October 1” and inserting “December 17”.

    Effective date note
    Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under subpart 3 of part C of subchapter VII of this chapter 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.

17. 2022

    Further Continuing Appropriations and Extensions Act, 2023

    Pub. L. 117–229 div. C title III § 309 · 136 Stat. 2308

    Substituted · 21 U.S.C. § 360m(c)

    Pub. L. 117–229 substituted “December 24, 2022” for “December 17, 2022”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–229 substituted “December 24, 2022” for “December 17, 2022”.

    Enacted provision · exact public law section
    SEC. 309. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.   Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “December 17, 2022” and inserting “December 24, 2022”.

18. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 div. FF title III § 3109 · 136 Stat. 4459

    Substituted · 21 U.S.C. § 360m(c)

    Pub. L. 117–328 substituted “on October 1, 2027” for “December 24, 2022”

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 117–328 substituted “on October 1, 2027” for “December 24, 2022”.

    Enacted provision · exact public law section
    SEC. 3109. REAUTHORIZATION OF THIRD-PARTY REVIEW PROGRAM.   Section 523(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m(c)) is amended by striking “December 24, 2022” and inserting “on October 1, 2027” .

22 of 22 references resolved to an enrolled provision