
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360m]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
                        Part A--Drugs and Devices
 
Sec. 360m. Accredited persons


(a) In general

              (1) Review and classification of devices

        Not later than 1 year after November 21, 1997, the Secretary 
    shall, subject to paragraph (3), accredit persons for the purpose of 
    reviewing reports submitted under section 360(k) of this title and 
    making recommendations to the Secretary regarding the initial 
    classification of devices under section 360c(f)(1) of this title.

                  (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 360c(f)(1) of this title 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 360(k) of this title 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 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.

        (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 360(k) of this 
        title were not required to be submitted by reason of the 
        operation of section 360(m) of this title.

(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 November 21, 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) of 
        this section. 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) of this section 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 393(g) of this title the names of all accredited 
        persons and the particular activities under subsection (a) of 
        this section 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) of this section 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 360(k) of this title 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) 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.

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


                             Effective Date

    Section effective 90 days after Nov. 21, 1997, except as otherwise 
provided, see section 501 of Pub. L. 105-115, set out as a note under 
section 321 of this title.


                   Reports on Program of Accreditation

    Section 210(d) of Pub. L. 105-115 provided that:
    ``(1) Comptroller general.--
        ``(A) Implementation of program.--Not later than 5 years after 
    the date of the enactment of this Act [Nov. 21, 1997], the 
    Comptroller General of the United States shall submit to the 
    Committee on Commerce [now Committee on Energy and Commerce] of the 
    House of Representatives and the Committee on Labor and Human 
    Resources of the Senate a report describing the extent to which the 
    program of accreditation required by the amendment made by 
    subsection (a) [enacting this section] has been implemented.
        ``(B) Evaluation of program.--Not later than 6 months prior to 
    the date on which, pursuant to subsection (c) of section 523 of the 
    Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(c)] (as added 
    by subsection (a)), the authority provided under subsection (a) of 
    such section will terminate, the Comptroller General shall submit to 
    the Committee on Commerce [now Committee on Energy and Commerce] of 
    the House of Representatives and the Committee on Labor and Human 
    Resources of the Senate a report describing the use of accredited 
    persons under such section 523, including an evaluation of the 
    extent to which such use assisted the Secretary in carrying out the 
    duties of the Secretary under such Act [21 U.S.C. 301 et seq.] with 
    respect to devices, and the extent to which such use promoted 
    actions which are contrary to the purposes of such Act.
    ``(2) Inclusion of certain devices within program.--Not later than 3 
years after the date of the enactment of this Act [Nov. 21, 1997], the 
Secretary of Health and Human Services shall submit to the Committee on 
Commerce of the House of Representatives and the Committee on Labor and 
Human Resources of the Senate a report providing a determination by the 
Secretary of whether, in the program of accreditation established 
pursuant to the amendment made by subsection (a), the limitation 
established in clause (iii) of section 523(a)(3)(A) of the Federal Food, 
Drug, and Cosmetic Act [21 U.S.C. 360m(a)(3)(A)] (relating to class II 
devices for which clinical data are required in reports under section 
510(k) [21 U.S.C. 360(k)]) should be removed.''

                  Section Referred to in Other Sections

    This section is referred to in sections 331, 360, 360c, 374 of this 
title.
