Sec. 205. Accreditation programs
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Section 514(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360d(d) ) is amended— in the subsection heading, by striking ; Pilot in paragraph (1)— in the matter preceding subparagraph (A), by striking pilot ; in subparagraph (A)— by inserting meeting criteria specified by the Secretary in guidance after testing laboratories ; by inserting in guidance after by the Secretary ; and by striking assess the conformance of a device with and inserting conduct testing to support the assessment of the conformance of a device to ; and in subparagraph (B)— by striking determinations and inserting results ; by inserting to support after so accredited ; and by striking a particular such determination and inserting particular such results ; in paragraph (2)— in the paragraph heading, by striking and inserting determinations ; results in subparagraph (A)— by striking determinations by testing laboratories and all that follows through such determinations or and inserting results by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the ; by inserting a comma after or testing laboratories ; by inserting or recognition of an accreditation body after accreditation of such testing laboratory ; and by striking such device and inserting a device ; and in subparagraph (B)— by striking by a testing laboratory so accredited and inserting under this subsection ; and by inserting or recognition of an accreditation body before under paragraph (1)(A) ; in paragraph (3)(C)— in the subparagraph heading, by inserting after and transition ; and initiation by adding at the end the following:
After September 30, 2023, such pilot program will be considered to be completed, and the Secretary shall have the authority to continue operating a program consistent with this subsection. ; and by striking paragraph (4). Section 523(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360m(c) ) is amended by striking 2022 and inserting 2027 .
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