On April 8, 2009, The Food and Drug Administration announced it would be ending loophole exploited for years by manufacturers. This loophole allowed all medical devices “manufactured and marketed” before the Medical Device Regulation Act of 1976. This meant that manufacturers did not have to show safety or effectiveness of a wide range of products from pacemaker parts to female condoms, and were exempt from the FDA’s usually scientific decisions.
The FDA classifies all medical devices into three categories: Class I (adhesive bandages and other items that pose little threat when used as intended), to Class III (pacemakers, breast implants, etc.). All Class III products must be shown to be both effective and safe before they are marketed, but those “types” of devices already marketed before 1976 did not have to apply for FDA approval.
At the act’s inception, Congress instructed the FDA to review the Class III devices subject to this loophole, but until the mid-90’s few of these “legacy devices” were actually reviewed. In 1994, there were over 150 different types of medical devices on the market which were not approved by the FDA. Today that number has been lowered to 27. This announcement affects 25 of these, while the process for the remaining two is already ongoing. Manufacturers have 120 days to send the FDA safety and effectiveness data related to the device as if they were applying for first-time approval.
Frankly, it’s about time this blatant loophole is closed. Perhaps taking over 30 years to complete what Congress had asked of the FDA attests to the complexity of the matter. Or, more likely, it’s another example of the FDA’s bureaucracy and the medical industry’s Washington lobbying.