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.

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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 been based on predicates more than a decade old as a means to encourage companies to adopt new predicates to support 510(k) devices. (Also see "Nudging Firms To Ditch Older Predicates: A Step In US FDA's Planned 510(k) Reforms" - Medtech Insight, 27 November, 2018

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