FDA Seeks To Streamline Medical Device Approvals

Law360, New York (January 3, 2012, 9:39 PM EST) -- The U.S. Food and Drug Administration has issued a new draft guidance intended to make its review process for low-risk medical devices more efficient, as part of an ongoing effort to streamline its application system.

The guidance, unveiled Dec. 28, lays out the FDA’s new recommendations for device makers seeking premarket approval for devices that are substantially equivalent to already-approved ones.

The FDA has taken a series of steps over the past year toward improving turnaround in its so-called 501(k) program, under which the agency approves...
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