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April 8, 2009

FDA Finally Closing Loophole on Most Grandfathered Medical Devices

Today, the FDA announced that manufacturers of 25 types of Class III medical devices marketed prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976 will finally be forced to submit safety and effectiveness data to the FDA before August 7, 2009. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Prior the 1976 law, Class III medical devices (examples of which include heart valves, external defibrillators, metal hip joints, female condoms, and pacemaker programmers just to name a few) were not required to undergo the usual pre-market approval process since they were considered "grandfathered" devices, meaning they were allowed on the market since they were substantially equivalent to devices already on the market. The FDA will review safety data for the 25 remaining device types and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit pre-market approval applications or will re-classify the devices into Class I or Class II. Today's announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a very stern January 2009 report to Congress.

Click here to read 4/8/09 FDA Press Release

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