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'Breakthrough' Blueprint: US FDA Draft Guideline Outlines Revised Expedited Development Program

 
• By David Filmore

The Breakthrough Devices Program is the established Expedited Access Pathway with some statutory updates, including the addition of 510(k)-pathway devices. But FDA also uses the congressionally-mandated draft guidelines to outline some new features in the program that are not in the statute, including a process for "breakthrough device sprint discussions."

Light bulb in a blue print

[Editors' note: For details on all devices for which companies have publicly disclosed designation for the Breakthrough/EAP program, check out Medtech Insight's US Expedited Access Tracker.]

US FDA introduced the concept of "sprint" discussions in a draft guidance posted Oct. 24 on the Breakthrough Devices Program

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