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Lenz, Principal Medical Device Regulation Expert & Holly N. The 21st Century Cures Act required FDA to publish in the Federal Register a list identifying types of CPs and manufacturing processes that may vary from the requirements of § 4.4, or that FDA proposes can satisfy the requirements in § 4.4 By Adrienne R. 880.6430 ).
Background The Breakthrough Devices Program, established under section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is a voluntary program for certain medical devices and device-led combination products. By Philip Won & Lisa M. Wysa, see here ) and addiction (e.g., reSET-O, see here , here ).
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