FDA Unveils Changes To Medical Device Review Process

Law360, New York (January 19, 2011, 7:13 PM EST) -- The U.S. Food and Drug Administration announced several changes Wednesday to its process for approving medical devices, including streamlined reviews for certain low-risk products, but held off on adopting some of the most controversial proposals.

The FDA will make 25 changes in 2011 to the review process 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.

Most new medical devices receive regulatory clearance under Section...
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