• Federal register · Nov 1991

    Assignment of agency component for review of premarket applications--FDA. Final rule.

    • Fed Regist. 1991 Nov 21; 56 (225): 58754-8.

    AbstractThe 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.

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