The US Food and Drug Administration (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comment period for its draft guidance on medical device 510(k) clearance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 the Federal
Register this week.
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