Federal Register 49374: Food & Drug Administration Breakthrough Devices Program; Draft Guidance

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff.” This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of breakthrough technologies, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to . . .