FDA MANDATORY RECALL DECISION SHOULD BE MADE WITHIN 10 DAYS
This article was originally published in The Gray Sheet
FDA MANDATORY RECALL DECISION SHOULD BE MADE WITHIN 10 DAYS after the agency issues a cease distribution and notification order, the Health Industry Manufacturers Association says in Sept. 9 comments on FDA's proposed rule on medical device recall authority. HIMA expresses concern that in the proposal "no deadline is established for FDA to issue its decision" on whether or not to require a device recall.
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