CDRH Plans To Redraft Maligned 510(k) Modifications Proposal

Article preview from "The Gray Sheet"-  April 23, 2012

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 Plans To Redraft Maligned 510(k) Modifications Proposal

Article preview from "The Gray Sheet"-  April 23, 2012

CDRH Director Jeffrey Shuren signaled the plans during an April 18 user fee reauthorization hearing before the House Energy & Commerce Health Subcommittee. Republicans on the subcommittee, citing widespread complaints from device companies, criticized the current draft guidance following Shuren’s testimony.

Companies say the policies outlined in the July 2011 draft document would lead to a big jump in the number of 510(k) submissions required for minor changes to products or labeling. In a survey of device companies conducted by AdvaMed, respondents estimated that the guidance would lead to a 300%-500% increase in 510(k) submissions for device modifications.

Once finalized, the document is intended to replace 1997 guidelines, which had caused some confusion among firms about when a new 510(k) was needed and when minor changes to a device could simply be documented internally by a company.

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