The US Food and Drug Administration said it is looking into ways to facilitate the approval of medical devices, Reuters reports. According to an FDA press release, part of the plan to improve the 510(k) approval process includes changing the review process for some lower-risk medical devices, specifying when a premarket submission should include clinical data, and creating a Center Science Council made up of FDA experts. The agency is also asking the Institutes of Medicine for its thoughts on the proposed changes, Reuters adds. Our sister publication GenomeWeb Daily News has more here.
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Jan 21, 2011