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PubMed

US regulatory compliance for medical combination products: an overview.

PMID: 39736921 ·

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JournalFrontiers in medical technology
Year
PMID39736921

Abstract

This article provides a high-level overview of US regulatory review and approval processes for the growing field of medical combination products (CPs; those merging drugs with devices and/or biological products). US law defines drugs, medical devices, and CPs in specific ways, and the components of a CP are still subject to their respective regulations while combined. The Food and Drug Administration's Office of Combination Products (OCP) oversees the review and classification of CPs, which is b

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