New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations
The FDA Law Blog
OCTOBER 17, 2023
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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