The FDA is extending the public comment period on a draft of one of its guidance documents for the medical device industry concerning 510(k) clearance for modified devices.
The federal watchdog agency said interested parties can submit comments on the draft guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device," until Nov. 28.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," according to a notice in the Federal Register.
The draft guidance is intended to update a 1997 guidance document, "Deciding When To Submit a 510(k) for a Change to an Existing 510(k)." It aims to clarify when a new 510(k) pre-market notification should be submitted for a change or modification to a device that’s already won 510(k) clearance.
Comments on the draft guidance can be submitted via http://www.regulations.gov or via snail mail to:
Division of Dockets
Food and Drug Administration,
5630 Fishers Lane, rm. 1061
Rockville, MD 20852