21 U.S. Code § 360m - Accredited persons
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.
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.
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.
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). 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.
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.
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.
Not later than 120 days after July 9, 2012, 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.
 See References in Text note below.
Section 360e–3 of this title, referred to in subsec. (a)(3)(A)(ii), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, § 901(f)(2), Aug. 18, 2017, 131 Stat. 1077.
2017—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.”
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.”
Subsec. (a)(3)(C). Pub. L. 115–52, § 206(1)(C), added subpar. (C).
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.”
Subsec. (b)(3)(E). Pub. L. 115–52, § 206(2)(B)(iii), added subpar. (E). Former subpar. (E) redesignated (F).
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.
Subsec. (c). Pub. L. 115–52, § 206(3), substituted “2022’ for “2017”.
2016—Subsec. (d). Pub. L. 114–255 struck out subsec. (d) which related to report to Congress.
2012—Subsec. (b)(2)(E). Pub. L. 112–144, § 611(a), added subpar. (E).
Subsec. (c). Pub. L. 112–144, § 611(b), substituted “October 1, 2017” for “October 1, 2012”.
2007—Subsec. (c). Pub. L. 110–85 substituted “2012” for “2007”.
2002—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.”
Subsec. (d). Pub. L. 107–250, § 202(2), added subsec. (d).
Amendment by Pub. L. 115–52 effective Oct. 1, 2017, 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, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.
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