(a) If, after providing the appropriate person with an opportunity to consult with the agency, FDA finds that there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, the agency may
CFR 21-810.10-2013 history
2013CFR 21-810.10-2013 Food and Drugs. Part810:Medical device recall authority. Section810.10:Cease distribution and notification order.