510(k) reform: IOM finally asks for medical device representation

April 1, 2011 by MassDevice staff

The Institute of Medicine is done with its review of the FDA's 510(k) clearance protocol and wants to hear from the medical device industry about its findings.

Adding some med-tech voices to the panel could help quell persistent complaints that the medical device industry has been woefully under-represented in the FDA's 510(k) reform process. The IOM's independent review is part of the Food & Drug Administration's push to revamp the protocol by which a vast majority of medical devices are cleared for market in the U.S.

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