FDA extends comment period on 510(k) modification draft notice

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The FDA has extended the comment period for a draft guidance for industry and FDA staff on 510(k) modifications including how to decide when to submit a 510(k) for a change to an existing device.

The original draft notice was published July 27 in the Federal Register. Comments will assist the FDA in the development of a final guidance for industry and FDA staff.

The comment period is now open until Nov. 28.

“The agency believes that this will allow adequate time for interested persons to submit comments without significantly delaying action by the agency,” the notice, dated Nov. 8, concluded.