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H.R. 2372IntroducedHouse · nowSenatePresidentLawIn committee
Sec. 2 · H.R. 2372

Reporting requirement for design and reprocessing instruction changes

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(a) Adulteration Section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph (j) the following: (k) If it is a device with respect to which the manufacturer is in violation of the reporting requirement under section 510(r) (relating to design and reprocessing changes).. (b) Requirement Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the following: (r) Reporting requirement for device design changes Before making a change to the design of a device, or the reprocessing instructions of a device, that is marketed in interstate commerce, the manufacturer of the device shall give written notice of the change to the Secretary..