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Comments Sought on Device Recall Authority

09/02/2005

Federal Register Notice: FDA is seeking public comment on a proposed collection of information entitled “Medical Device Recall Authority — 21 CFR Part 810.” This collection implements medical device recall authority provisions under FDCA Section 518(e) and Part 810 and gives FDA the authority to issue an order requiring the appropriate person, including manufacturers, importers, distributors, and retailers of a device, to immediately cease distribution of such device, to immediately notify health professionals and device-user facilities of the order, and to instruct such professionals and facilities to cease use of such device, if FDA finds that there is reasonable probability that the device would cause serious adverse health consequences or death. Comments should be submitted by 11/1. To view this notice, click here.

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