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Proposed 510(k) Changes Elicit Some Industry Skepticism

 
• By Elizabeth Orr

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

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US FDA has made moves this year toward reforming its 510(k) program for faster, more predictable clearances. But industry still seems uncertain as to which of the changes will show a real impact on the ground.

Two new pilot programs are launching this fall, the Quality in 510(k) "Quik" Review program pilot and the Special 510(k) program pilot. It’s unclear what the ultimate effect of the...

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