§ 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—
(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—
(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:
(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.
(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—
(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.
(d)
Report
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 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—
(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) of this section 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
360
(k) of this title;
(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;