FDA Device Center Plans Review To Resolve or Drop Pending Draft Guidance

NEW YORK—The Center for Devices and Radiological Health at the Food and Drug Administration plans to undertake a priority review of all outstanding draft guidance documents for medical device reviews to determine whether they should be finalized or withdrawn, the center’s deputy director said Jan. 26.

Speaking in a panel discussion at the annual meeting of the Food, Drug, and Cosmetic Law section of the New York State Bar Association, Nancy K. Stade said that the sweeping review of pending draft guidance documents would be among the center’s priorities when they are announced for 2012.

She was responding to comments ...