Scrutinizing Substantial Equivalence: 510(k) Predicate Standard Questioned At FDLI
This article was originally published in The Gray Sheet
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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510(k) clearances are the US market on-ramp for most devices, and proving the device is similar enough to an already-marketed product is the entry toll. But a policy in development at FDA's device center offers an optional approach that avoids predicate comparisons. Center director Jeffrey Shuren says in an interview that he expects the new approach will become the "pathway of choice" for many companies, potentially upending what has been a defining characteristic of the device regulatory landscape for decades.
FDA intends to draft a guidance by March outlining a voluntary, alternative 510(k) pathway for sponsors to demonstrate the substantial equivalence of some products by relying more on objective performance criteria.
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