Medical device recall authority--FDA. Final rule.
The Food and Drug Administration (FDA) is establishing procedures for implementing the medical device recall authority provided in the Safe Medical Devices Act of 1990 (the SMDA). This statutory authority protects the public health by permitting FDA to remove dangerous devices from the market promptly. This authority complements other provisions of the device law, including tracking and notification.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration