Sec. 605. Facilitating international harmonization
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Section 704(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374(g) ) is amended by adding at the end the following: Notwithstanding any other provision of this subsection, for purposes of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process devices except types of devices licensed under section 351 of the Public Health Service Act, which inspections are required under section 510(h) or are inspections of such establishments required to register pursuant to section 510(i), the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization.
Nothing in this paragraph affects the authority of the Secretary to inspect any device establishment pursuant to this Act. Nothing in this paragraph affects the authority of the Secretary to determine the official classification of an inspection. .
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Sec. 605
Facilitating international harmonization
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