Older Medical Devices To Get Safety ReviewsApr 9, 2009 | Parker Waichman LLP
U.S. regulators are finally going to review 25 types of medical devices that were marketed prior to 1976. According to a statement from the Food & Drug Administration (FDA), all of the medical devices slated for review were introduced prior to enactment of the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976, and have never been subjected to the rigorous evaluations that are required by the law.
All of the medical devices subject to the new review are Class III medical devices. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed.
After Congress enacted the medical device law in 1976, the FDA classified these 25 devices types as Class III. According to The Wall Street Journal, in 1990 Congress ordered the FDA to gather rigorous evidence before a manufacturer can sell a Class III medical device. But the agency never finished the process, and has allowed hundreds of these devices to be sold based on less rigorous evaluations showing that they are "substantially equivalent" to combinations of other products marketed before 1976. According to the Journal, this type of evaluation does not require that the devices undergo patient clinical trials.
According to the FDA statement, the medical devices that are subject to the new review include heart valves and intraocular lenses. Manufacturers of these medical devices must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.
The agency has given medical device manufacturers 120 days to submit the required information. At the end of its review, the FDA will issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II. It could take the agency several years to finish the process.
The FDA's oversight of medical devices has long been the subject of criticism. While consumer advocates are in favor of the agency efforts to review the safety of Class III devices, they say the whole approval process needs an overhaul.
“It’s great that FDA is finally going to look at pre-1976 devices, but the bigger problem is the low standards for approving any and all devices without clinical trials or any proof of safety or effectiveness,” Diana Zuckerman, president of the National Research Center for Women and Families, told The New York Times.