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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...

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