U.S Code last checked for updates: May 05, 2024
All TitlesTitle 21Chapter 9Subchapter VPart A
§ 360m.
Accredited persons
(a)
In general
(1)
Review and classification of devices
(2)
Requirements regarding review
(A)
In general
(B)
Time period for review
(C)
Special rule
(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 device classified under section 360c(f)(2) of this title or designated under section 360e–3(d) 1
1
 See References in Text note below.
of this title;
(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).
(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issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an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not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and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).
(C)
Interim rule
(b)
Accreditation
(1)
Programs
(2)
Accreditation
(A)
In general
(B)
Withdrawal of accreditation
(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)
Periodic reaccreditation
(i)
Period
(ii)
Response to reaccreditation request
(iii)
Criteria
(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.
(F)
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—
(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
(5)
Compensation of accredited persons
(c)
Duration
(June 25, 1938, ch. 675, § 523, as added Pub. L. 105–115, title II, § 210(a), Nov. 21, 1997, 111 Stat. 2342; amended Pub. L. 107–250, title II, § 202, Oct. 26, 2002, 116 Stat. 1609; Pub. L. 110–85, title II, § 221, Sept. 27, 2007, 121 Stat. 852; Pub. L. 111–31, div. A, title I, § 103(f), June 22, 2009, 123 Stat. 1837; Pub. L. 112–144, title VI, § 611, July 9, 2012, 126 Stat. 1059; Pub. L. 114–255, div. A, title III, § 3102(4), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title II, § 206, Aug. 18, 2017, 131 Stat. 1018; Pub. L. 117–180, div. F, title II, § 2006, Sept. 30, 2022, 136 Stat. 2154; Pub. L. 117–229, div. C, title III, § 309, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, § 3109, Dec. 29, 2022, 136 Stat. 5808.)
cite as: 21 USC 360m
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