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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 deputy director of the FDA device center’s Office of Product...

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