Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff January 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-0078
• Issued by: Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Center for Drug Evaluation and Research; Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products

Section 3038 of the 21st Century Cures Act, enacted in December 2016 (P.L. 114-255) (“Cures Act”), substantially amended section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 353(g)), the principal section of the FD&C Act expressly addressing combination products. General themes of these amendments include enhancing clarity, predictability, efficiency, and consistency of premarket regulatory expectations for combination products, including by ensuring that Agency components and staff coordinate appropriately on premarket review of these products, and that Agency thinking is aligned in conducting these reviews. FDA is publishing this guidance as part of its efforts to implement Cures Act section 3038 and in keeping with the Agency’s long-standing commitment to transparency, efficiency, and regulatory consistency, to facilitate development of safe and effective combination products.

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