Sec. 515. Strengthening medical device supply chains
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Section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ) is amended— by redesignating subsections
(h)and
(i)as subsections
(j)and (k), respectively; and by inserting after subsection
(g)the following: Each manufacturer of a device that is critical to public health, including devices that are life-supporting, life-sustaining, or intended for use in emergency medical care, shall develop, maintain, and, as appropriate, implement a redundancy 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. A risk management plan under this subsection— may identify and evaluate risks to the supply of more than one 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. . Not later than 2 years after the date of enactment of this Act, and annually for 4 years thereafter, the Secretary of Health and Human Services shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on the use of information manufacturers submit pursuant to section 506J of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ) and applicable guidance issued with respect to such section.
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Sec. 515
Strengthening medical device supply chains
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