FDA Says Guidelines On Device Review, Recalls Are Priorities

Law360, New York (November 26, 2012, 6:29 PM EST) -- The U.S. Food and Drug Administration plans to release a raft of guidance documents over the next year on the agency's regulation of medical devices, including guidelines on the 510(k) process, recalls, communication during the review process and custom devices, the agency said Friday.

The FDA's Center for Devices and Radiological Health agreed, as part of this year's medical device user fee agreement, to announce annually which guidance documents it plans to release over the next year.

The FDA relies heavily on nonbinding guidance documents to...
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