FDA Issues 510(k) Modifications Draft Guidance
This article was originally published in The Gray Sheet
FDA is taking another stab at giving device companies advice on how to tell if a change they make to a 510(k)-cleared product warrants a new pre-market submission.
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Center Director Jeffrey Shuren says it was not CDRH’s intention to force more 510(k)s for device modifications with its July 2011 draft guidance. The center plans to take the unusual step of issuing a revised draft to respond to industry complaints.
Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.