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Comments Sought on Device Recall Authority

11/16/2011

Federal Register Notice: FDA is seeking public comment on the information collection requirements for medical device recall authority. FDCA 518(e) provides FDA with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device, if the agency finds that there is reasonable probability that the device intended for human use would cause serious adverse health consequences or death, to: (1) Immediately cease distribution of such device, (2) immediately notify health professionals and device-user facilities of the order, and (3) instruct such professionals and facilities to cease use of such device. Comments should be submitted by 1/17/12. To view this notice, click here.

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