On April 9th of this year the Food and Drug Administration (FDA) announced in the Federal Register that manufacturers of twenty-five Class III pre-amendment devices would be required to submit a summary of safety and efficacy information, including that information which had not been submitted under section 519 of the Food, Drug, and Cosmetic Act (FD&C Act). The twenty-five devices identified are those Class III pre-amendment devices for which a final regulation requiring the submission of a PMA has yet to be issued. These devices were marketed in the U.S. prior to the Medical Device Amendments made to the FD&C Act of 1976 legislation which authorized the FDA to review new medical devices. This announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accounting Office (GAO). Click here to see if your device is on this list.