FDA held a public meeting June 13 at its Silver Spring, Md., headquarters to discuss possible changes to its policy on when sponsors must submit a new 510(k) for a modification to an existing device. The meeting was held in response to a provision in the FDA Safety and Innovation Act requiring the agency to seek stakeholder feedback in preparation for a report on its 510(k) modification policy, which is due to Congress in January. (See Also see "FDA Subject To More Oversight Following User Fee Bill Passage" - Medtech Insight, 2 July, 2012..) This provision was enacted after FDA withdrew a controversial 510(k) modification draft guidance in 2012 in response to widespread opposition from device-makers. (See Also see "CDRH Plans To Redraft Maligned 510(k) Modifications Proposal" - Medtech Insight, 23 April, 2012..)
Prior to the meeting, AdvaMed submitted a white paper saying FDA’s 1997 guidance, along with the current medical device and quality system regulations, were sufficient. The trade group...
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