In the News

Manufacturers of Certain Medical Devices Originally Marketed Prior to 1976 Must Submit Safety Data to FDA

Apr 23, 2009

The U.S. Food and Drug Administration (FDA) announced on April 8, 2009 that current manufacturers of 25 types of Class III medical devices originally marketed prior to 1976 must submit to the Agency safety and effectiveness information that has not previously been provided. In a Federal Register (74 Fed. Reg. 16214, April 9, 2009) notice detailing the new requirement, FDA stated that this information will be used to determine if the classification for each device should be revised to require the submission of a premarket approval application (PMA) or a notice of completion of a Product Development Protocol (PDP), or whether the device should be reclassified as a Class I or II device.

The Medical Device Amendments of 1976 (modifying the Federal Food, Drug, and Cosmetic Act) authorized FDA to review new medical devices. In a press release on the announcement, FDA said that this 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 Accountability Office (GAO) in a January 2009 report to Congress.

"We are taking the necessary steps to complete this very complex process while continuing to protect public health by thoroughly reviewing and evaluating all medical device submissions presented to the agency. New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness," Daniel G. Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, explained in the release.

Manufacturers of the 25 device types—which include two types of metal hip joints, several devices related to pacemakers, and membrane lungs—must submit the requested information by August 7, 2009.