Fed Regist. 1991 Nov 21;56(225):58754-8.
The Food and Drug Administration (FDA) is promulgating a new regulation to describe how the agency will determine which component within FDA will have primary jurisdiction for the premarket review and regulation of: (1) A combination drug, device, or biologic product or (2) any drug, device, or biologic product where the center with primary jurisdiction is unclear or in dispute. This rule describes how to identify the agency's assigned review component which will, in most cases, eliminate the need for a sponsor to obtain approval from more than one FDA component for a combination product.
美国食品药品监督管理局（FDA）正在颁布一项新规定，以说明该机构将如何确定FDA内部哪个部门对以下产品的上市前审查和监管具有主要管辖权：（1）组合药物、器械或生物制品；或（2）主要管辖权中心不明确或存在争议的任何药物、器械或生物制品。本规则描述了如何确定该机构指定的审查部门，在大多数情况下，这将使申办者无需就组合产品获得FDA多个部门的批准。
