The FDA published this draft guidance on the Breakthrough Devices program in October 2017. You can submit your comments on the draft guidance, which describes the policies that the agency intends to use to implement the program, by December 26, 2017. On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which . . .
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