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An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain

 
• By Elizabeth Orr and David Filmore

The device industry is still sorting out the implications of US FDA's recent proposals to make what the agency describes as a major update to the 510(k) process. But regulatory experts say the agency's focus on finding an age-based cut-off for 510(k) predicate devices is misguided, and some argue that Congress should need to sign off on any of the floated policies.

Business development idea and developing industry success through creative invention as a light bulb evolving to a gear shape as a 3D illustration.

There are still many details to be worked out with US FDA's plans to reform the 510(k) process, but expert observers suggest the agency's focus on favoring newer predicates may result in arbitrary policies.

The agency floated reform proposals last month, including the possibility of publishing a list of all cleared devices that had...

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More from Policy & Regulation

No EUDAMED, No Market: ‘Waiting Until Mandatory Deadline Is Risky’

 
• By Natasha Barrow

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Oura Gets Competitors Banned From US Market, But Faces Ultrahuman Countersuit

 
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