FDA Clarifies When Medical Device Changes Need Approval

Law360, New York (July 28, 2011, 4:35 PM EDT) -- The U.S. Food and Drug Administration laid out new guidelines Wednesday for when medical device makers should request another clearance on devices they have altered in some way, focusing on changes in technology that call for agency approval.

The draft guidance addresses the FDA's thinking on the review process for devices under Section 510(k) of the Federal Food, Drug and Cosmetic Act, which allows lower-risk medical devices to be marketed if they are substantially equivalent to devices already on the market. If a company makes a...
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