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

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...