Refer A Colleague FDA to Review Devices Marketed Prior to 1976
The U.S. Food and Drug Administration (FDA) recently announced that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the agency so that it may evaluate the risk level for each device type. Devices found by FDA to be of high risk to consumers will be required to undergo the agency’s most stringent premarket review process.
These 25 device types, which are listed in a Federal Register announcement posted recently, were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized FDA to review new medical devices. 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 January 2009 report to Congress.
FDA classifies medical devices into three categories according to their level of risk. Class III devices represent the highest level of risk, and generally require a showing of safety and effectiveness before they may be marketed. Class III devices include heart valves and intraocular lenses. Class I and Class II devices pose lower risks and include devices such as adhesive bandages and wheelchairs. Most Class II devices and some Class I devices are marketed after submission of premarket notifications establishing their substantial equivalence to legally marketed devices that do not require premarket approval.
Manufacturers of the 25 device types must submit the requested information within 120 days. FDA will review the submitted data and, based on the risk level, 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.
For more information, visit http://www.fda.gov/bbs/topics/NEWS/2009/NEW01990.html.