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Whitepapers

Combination Products: A 40 Year Regulatory Evolution

The White Paper entitled, “Combination Products: A 40 Year Regulatory Evolution” by NSF Health Sciences Medical Devices provides an overview of FDA’s approach to regulating combination products, implications for industry, and the FDA’s plans for the future of combination product regulation. It contains information on a wide range of related information such as the "Current Good Manufacturing Practice Requirements for Combination Products” (21 CFR Part 4) and "The Office of Combination Products" (OCP).