(a) This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device cor
CFR 21-806.1-2014 history
2014CFR 21-806.1-2014 Food and Drugs. Part806:Medical devices; reports of corrections and removals. Section806.1:Scope.