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Sprinting To Approval: Insider Tips On FDA’s Breakthrough Devices Program

 
• By Elizabeth Orr

Manufacturers applying to the program should be ready for questions from the US agency, an FDA official says.

The shoe, legs and hands of a crouched runner in starting position, seen from behind.
• Source: Alamy

Want to get a device cleared for market via the US Food and Drug Administration’s breakthrough devices pathway? Then get ready to work closely with the agency during the 60-day review “sprint,” a lead agency official says.

The breakthrough timeline as laid out in statute and followed by agency review teams is tight, said Owen Faris, principal...

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