From the FDA:
The FDA today 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 the 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 the Federal Register announcement posted today, were 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. 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.
Detail from the site:
|External cardiac compressor||870.5200||LIX, DRM|
|External counter-pulsating device||870.5225||DRN|
|Automated external defibrillator||870.5310||NPN, NSA, MKJ|
Filed under: Uncategorized |