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FDA's Alternative 510(k) Proposal Falls Flat With Industry

 
• By David Filmore

The US regulatory agency has touted its newly proposed voluntary "expanded abbreviated" 510(k) program as a modern approach to regulation that will simplify the path for many. But industry groups are mostly scratching their heads.

The word Meh written on a blackboard in white chalk as an expression of boredom or indifference when giving an opinion

US FDA may be overselling the benefits of its newly proposed alternative 510(k) pathway without much backing, industry groups suggest.

The agency issued a draft guidance in April outlining plans for a voluntary program that would allow a company to prove its device is as safe and effective as...

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More from Policy & Regulation

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