Sec. 2262. Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions
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Section 520 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(j) ) is amended— in subsection (g)(3)— by striking local each place it appears; and in subparagraph (A)(i), by striking which has been ; and in subsection (m)(4)— by striking local each place it appears; and by striking subparagraph
(A)and inserting the following new subparagraph: in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary, and . Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise or issue such regulations or guidance as may be necessary to carry out the amendments made by subsection (a).
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Sec. 2262
Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions
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