Regulatory News In Brief

FDA will hold a public workshop May 17 in Silver Spring, Md., to discuss FDA’s “past, present and future policy” on when manufacturers should submit a new 510(k) for a change to an existing device. FDA issued its draft 510(k) modification guidance in August 2011 which was met with opposition from industry representatives complaining it would lead to more 510(k) submissions. (See Also see "A “Disastrous” Draft? Device Firms Take Issue With 510(k) Modifications Guidance" - Medtech Insight, 5 December, 2011..) While FDA claimed increasing submissions was not the intent of the guidance, the agency decided to withdraw it and issue a new one in the future. (See Also see "CDRH Plans To Redraft Maligned 510(k) Modifications Proposal" - Medtech Insight, 23 April, 2012..) Last year’s FDA Safety and Innovation Act required FDA to issue a report to Congress within 18 months after the law’s enactment describing its 510(k) modification policy before the agency could issue a new 510(k) guidance. (See Also see "FDA Subject To More Oversight Following User Fee Bill Passage" - Medtech Insight, 2 July, 2012..)

The agency is soliciting comment from stakeholders as written submissions to the docket or during the discussions in the meeting. FDA is asking for examples of device modifications that would...