FDA Extends Comment Period on 510(k) Guidance
The FDA has extended the public comment period for its draft guidance on medical device 510(k) clearance for modified devices. The draft, entitled “510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device,” is open for stakeholders and the public to submit comments until 28 November. “The agency believes that this will allow adequate time for interested persons to submit comments without significantly delaying action by the agency,” according to the notice published in theFederal Register this week.
To read the draft guidance click here.
- No comments Posted in: Device Approval, Medical Device News (FDA) Tags: 510(k), device, FDA, medical device, modification, PMA, premarket approval, Special 510(k)
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