The Food and Drug Administration issued an order requiring manufacturers of 25 types of medical devices marketed prior to 1976 to submit safety and effectiveness information. Devicemakers have 120 days to turn over the information, which the FDA will use to evaluate the risk level for each device type.
The mandate comes in response to a January report by the Government Accountability Office, which found that the FDA had failed to complete evaluations of many pre-1976, Class III medical devices more than three decades after a law authorizing the agency to review all new devices went into effect. Class III devices are considered high-risk and typically include implants such as heart valves and intraocular eye lenses.
Class III devices on the market prior to 1976 were not immediately required to undergo the premarket review process, but the FDA was required to issue a rule subjecting devices within the 25 identified categories to eventually undergo the review process. As of 1994, however, more than 149 types of pre-1976, Class III devices had yet to undergo review and approval, according to an FDA news release.
Several pacemaker device components as well as hip and spinal implant products are included among the product categories.
The newly issued review plan calls for FDA officials to evaluate the submitted efficacy and safety data, and, based on each devices assessed risk level, either reclassify the devices into the lower-risk Class I or II categories, or require manufacturers to submit premarket approval applications for their devices.