"Grandfathered in" Medical Devices Required to Submit Safety Data

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Wednesday, April 8, 2009, the FDA announced that medical devices manufactured prior to 1976 and “grandfathered in” will now be required to submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type.

The list includes 25 medical device types which were manufactured and marketed in the U.S. 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, but allow those already in use to be “grandfathered in” with the stringent testing required today.

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The FDA classifies medical devices into three categories according to their level of risk. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Class III devices represent the highest level of risk and include heart valves, pacemakers, breast implants, and intraocular lenses. In general, Class III devices require a showing of safety and effectiveness before they may be marketed.

In 1994, there were approximately 149 Class III, pre-1976 types of medical devices that had not been subject to premarket approval. The FDA has made significant progress in reviewing and issuing new regulations for all but 27 of those device types. The remaining manufacturers of these must submit the requested information within 120 days for the FDA to review.

A complete list may be found at the Federal Register notice
http://www.federalregister.gov/OFRUpload/OFRData/2009-08022_PI.pdf

Link to FDA’s Center for Devices and Radiological Health Web site
http://www.fda.gov/cdrh/classiii.html

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