Assignment of agency component for review of premarket applications--FDA. Final rule.
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.
D001688:Biological Products / Q000592:standards; D002986:Clinical Trials as Topic; D003657:Decision Making; D004341:Drug Evaluation; D004864:Equipment and Supplies / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration*
D001688:Biological Products