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Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff February 2019


Not for implementation. Contains non-binding recommendations.

Principles of Premarket Pathways for Combination Products

Docket Number:
Issued by:
Guidance Issuing Office
Office of Combination Products
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

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.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-0078.


Contact Point
Combination Products Guidance Contact
Office of Combination Products
Office of Special Medical Programs, Office of the Commissioner
John Barlow Weiner