Assignment of Agency Component for Review of Premarket Applications

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The Food and Drug Administration (FDA) is revising its regulations concerning FDA's procedures for determining which component within FDA will have primary jurisdiction for the premarket review and regulation of a product composed of a combination of a drug, device, or biological product; or any drug, device, or biological product where the agency component with jurisdiction is unclear or in dispute. FDA is taking this action to implement the requirement of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) that FDA establish an office within FDA's Office of the Commissioner to ensure the prompt assignment of combination products to agency centers.