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

This article was originally published in The Gray Sheet

Executive Summary

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.

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