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CDRH Plans To Redraft Maligned 510(k) Modifications Proposal

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Jeffrey Shuren says it was not CDRH’s intention to force more 510(k)s for device modifications with its July 2011 draft guidance.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.

FDA’s device center is reworking its controversial draft 510(k) modifications guidance with the intent to issue a revised draft before finalizing a new policy.

CDRH Director Jeffrey Shuren signaled the plans during an April 18 user fee reauthorization hearing before the House Energy &...

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