The Food and Drug Administration unveiled draft guidance Wednesday on how it reviews applications for low-risk medical devices under the 510(k) program and is requesting industry comment.
The FDA has been working with industry and patient advocacy groups to overhaul its so-called 510(k) program, which medical device makers complain has grown too complicated and uncertain. The draft guidance is not final and is not currently in effect, but gives stakeholders a chance to comment before the agency begins to develop its final guidance.
Comments are due by April 26, 2012.
Julian Pecquet – The Hill/Heath Watch Blog 12/29/11