FDA to review risks for older devices
Device Regulation Alert: Safety, Compliance and Reimbursement News, April 13, 2009
Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and effectiveness information to the FDA for a risk evaluation, the agency announced April 8.
The FDA approved the devices prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act. The Federal Register lists the affected devices and outlines what information manufacturers must provide.
Manufacturers must submit the requested information within 120 days. The FDA will review the submitted data and either require manufacturers to submit pre-market approval applications or will re-classify the devices into Class I or Class II.
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