21 U.S.C. § 360m : US Code - Section 360M: Accredited persons

Search 21 U.S.C. § 360m : US Code - Section 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 October 1,
2007.
(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 -
(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) 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;
(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 360(k) of this title;
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.