On April 9, 2009, FDA published an Order in the Federal Register requiring manufacturers of twenty-five (25) Class III preamendments devices to submit to FDA a summary of, and citation to, any known, or otherwise available, safety or efficacy information, including that information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i).
