Fed Regist. 1991 Nov 21;56(225):58758.
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.
美国食品药品监督管理局（FDA）正在修订授权委托的相关规定，以便将专员依据《联邦食品、药品和化妆品法案》（《美国法典》第21编第353(g)(1)条）（1990年《安全医疗器械法案》的一项条款）对组合产品上市前审查和监管指定主要管辖权的权力重新委托给专员办公室的监察员，即产品管辖权官员。根据本期《联邦公报》其他地方公布的一项规定，FDA监察员为指定的产品管辖权官员。
