According to the United States Institute of Medicine, it is time for the Food and Drug Administration to make a few changes after 35 years of the same methods. In a recently released report, the group has hopes of changing the way the agency regulates medical devices.
Most medical devices make it to the market through the fast-track 510(k) process of approval, which is the vanguard of pending discussions.
The document requested by the US Food and Drug Administration is anticipated to recommend that medical devices, including pacemakers and artificial joints be put through a more arduous approval process before they are permitted release on the market.
According to Section 510(k) of the Food, Drug and Cosmetic Act, medical device manufacturers are required to register and notify the Food and Drug Administrat
ion that they intend to market that medical device a minimum of ninety days prior to action. This is referred to officially as Premarket Notification, or PMN.
This way, it is possible for the Food and Drug Administration to determine if the medical device is comparable to a medical device that is already in place in one of the classification categories. New medical devices that are unclassified will still be identifiable.
To be more specific, medical device manufacturers have to submit a premarket notification to the FDA, which states their intentions to introduce a new medical device into commercial distribution or to reestablish a medical device that has been altered significantly in a way that effectiveness and safely may have been affected. These modifications and changes may relate to material, design, chemical composition, manufacturing process, energy source or the intended use of the device.
According to the deputy director of Public Citizen’s Health Research Group Dr. Michael Carome, “FDA’s oversight and review process is too weak and needs to be strengthened. We believe that the process for approving devices under the 510(k) program frequently is deficient because of the application and the loose interpretation of what it means to be ’substantially equivalent to a predicate device.”
photo credit: mullica