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Market Fast Track Or Regulatory Trap? Consultant Ken Block On US FDA’s Breakthrough Devices Program

 
• By Ryan Nelson

Ken Block of Ken Block Consulting weighs in on the FDA’s Breakthrough Devices Program, its implications for raising capital, achieving speedier market access, and inviting more intensive regulatory scrutiny in this interview with Medtech Insight.

• Source: Shutterstock

Speaking with Medtech Insight on 29 August, medtech industry consultant Ken Block said he’d just wrapped a call with a client and a US Food and Drug Administration representative regarding the former’s novel medical device.

He explained, “It's a kind of a marketing-related call that FDA does” to say, “‘We’ve identified your company as having a novel device.’”

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