Sec. 2005. CONFORMITY ASSESSMENT PILOT PROGRAM
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## SEC. 2005 CONFORMITY ASSESSMENT PILOT PROGRAM Section 514(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(d)) is amended to read as follows: > > ### “(d) Accreditation Scheme for Conformity Assessment > > > #### “(1) In general > > The Secretary shall establish a program under which— > > > ##### “(A) > > testing laboratories meeting criteria specified in guidance by the Secretary may be accredited, by accreditation bodies meeting criteria specified in guidance by the Secretary, to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section; and > > > ##### “(B) > > subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices as described in subparagraph
(A)conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the Secretary for purposes of demonstrating such conformity unless the Secretary finds that certain results of such tests should not be so accepted. > > > #### “(2) Secretarial review of accredited laboratory results > > The Secretary may— > > > ##### “(A) > > review the results of tests conducted by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories; > > > ##### “(B) > > following such review, take additional measures under this Act, as the Secretary determines appropriate, such as— > > > ###### “(i) > > suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or > > > ###### “(ii) > > requesting additional information with respect to a device; and > > > ##### “(C) > > if the Secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this Act, as the Secretary determines appropriate, such as— > > > ###### “(i) > > suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or > > > ###### “(ii) > > requesting additional information with regard to such device. > > > #### “(3) Report > > The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the program under this subsection.” > .
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Sec. 2005
CONFORMITY ASSESSMENT PILOT PROGRAM
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