Delegations of authority and organization; Office of the Commissioner--FDA. Final rule.
The Food and Drug Administration (FDA) is amending the regulations for delegations of authority to redelegate the Commissioner's authority to designate primary jurisdiction over the premarket review and regulation of combination products under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)(1)) a provision of the Safe Medical Devices Act of 1990 to the ombudsman as the product jurisdiction officer, Office of the Commissioner. Under a regulation published elsewhere in this issue of the Federal Register, the FDA ombudsman is the designated product jurisdiction officer.
D001688:Biological Products / Q000592:standards; D003254:Consumer Advocacy / Q000331:legislation & jurisprudence; D004341:Drug Evaluation; D004864:Equipment and Supplies / Q000592:standards; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
D001688:Biological Products