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US FDA introduced the concept of "sprint" discussions in a draft guidance posted Oct. 24 on the Breakthrough Devices Program

The name change comes from Congress. The 21st Century Cures Act, enacted last December, establishes the Breakthrough Devices Program as an accelerated development pathway intended for devices that FDA finds could provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, addressing an unmet need

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