Sec. 205. Conformity assessment pilot program
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Section 514 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360d ) is amended by adding at the end the following: The Secretary shall establish a pilot program under which— testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the Secretary, to assess the conformance of a device with certain standards recognized under this section; and subject to paragraph (2), determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the Secretary for purposes of demonstrating such conformity under this section unless the Secretary finds that a particular such determination shall not be so accepted.
The Secretary may— review determinations by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and, following such review, taking additional measures under this Act, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A) or requesting additional information with respect to such device, as the Secretary determines appropriate; and if the Secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited, take such additional measures under this Act as the Secretary determines appropriate, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A), or requesting additional information with regard to such device.
The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than September 30, 2018, to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the pilot program under this subsection. The Secretary shall— not later than September 30, 2019, issue draft guidance regarding the goals and implementation of the pilot program under this subsection; and not later than September 30, 2021, issue final guidance with respect to the implementation of such program.
Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection. The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the pilot program under this subsection. As of October 1, 2022— the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph (1)(A) shall cease to have force or effect; the Secretary— may not accept a determination pursuant to paragraph (1)(B) made by a testing laboratory after such date; and may accept such a determination made prior to such date; except for purposes of accepting a determination described in subparagraph (B)(ii), the Secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph (1)(A); and the Secretary may take actions in accordance with paragraph
(2)with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date. .
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Sec. 205
Conformity assessment pilot program
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