FDA to Review Medical Devices Marketed Before 1976

Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the U.S. Food and Drug Administration (FDA) so that it may evaluate the risk level for each device type, according to agency officials.

Devices found by the FDA to be of high risk will be required to undergo the premarket review process.

“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,” said Daniel G. Schultz, director of the FDA’s Center for Devices and Radiological Health. “New premarket notification submissions for devices of these 25 types will continue to receive an appropriate level of scrutiny to ensure safety and effectiveness.”

These device types were marketed in the United States prior to the medical device amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized the FDA to review new medical devices. This requirement is the first toward completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office in January.

The FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses.

The Advanced Medical Technology Association supports the action by the FDA, but said that some of the devices have already been reviewed.

“AdvaMed is pleased that FDA has moved expeditiously to begin the process for making final classification determinations for the remaining 25 Class III device types that pre-dated the 1976 Medical Device Amendments. However, it needs to be clearly understood that the device types subject to the FDA notice have already been thoroughly reviewed by the agency involving the submission and evaluation of relevant technological and performance data, and in some cases, clinical data. We believe these devices should be regulated by the agency commensurate with their risk profile, and the information that will be provided to FDA will allow the agency to determine whether each device type should be reclassified into Class I or Class II or require submission of a premarket approval application,” said Janet Trunzo, executive vice president of technology and regulatory affairs.