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Scrutinizing Substantial Equivalence: 510(k) Predicate Standard Questioned At FDLI

Consultant and Food & Drug Law Institute Chair Sheila Hemeon-Heyer said it is time to remove the substantial equivalence mandate from the 510(k) program at the FDLI annual conference April 20. “The Gray Sheet” spoke to Hemeon-Heyer and CDRH Director Jeffrey Shuren about the idea.

At the April 20 Food Drug Law Institute meeting in Washington, D.C., consultant and FDLI Chair Sheila Hemeon-Heyer, told the FDLI audience that it might be time to remove substantial equivalency requirements from 510(k) provisions.

In an interview with “The Gray Sheet,” Hemeon-Heyer, who runs Heyer Regulatory Solutions and previously worked at FDA and in the device industry, said it has “become increasingly difficult for manufacturers to find predicate devices,” for the newest devices, and laid out reasons why

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