Sec. 522. Supply chain risk management
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/bill/118/hr/4697/ih/section-522A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ) is amended by striking subsection
(h)and inserting the following: Each manufacturer of a device described in subsection
(a)shall develop, maintain, and, as appropriate, implement a risk management plan that identifies and evaluates risks to the supply of the device, as applicable, for each establishment in which such device is manufactured. Such risk management plan— may identify and evaluate risks to the supply of more than 1 device, or device category, manufactured at the same establishment; and shall be subject to inspection and copying by the Secretary pursuant to section 704 or at the request of the Secretary. . Section 506J(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j(f) ) is amended by striking or
(h)after subsection
(a).
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Sec. 522
Supply chain risk management
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