CFR 21-806.20-2013 Food and Drugs. Part806:Medical devices; reports of corrections and removals. Section806.20:Records of corrections and removals not required to be reported.
(a) Each device manufacturer or importer who initiates a correction or removal of a device that is not required to be reported to FDA under § 806.10 shall keep a record of such correction or removal.
CFR 21-806.20-2013 history
2013CFR 21-806.20-2013 Food and Drugs. Part806:Medical devices; reports of corrections and removals. Section806.20:Records of corrections and removals not required to be reported.