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Principles of premarket pathways for combination products: guidance for industry and FDA Staff
Principles of premarket pathways for combination products: guidance for industry and FDA Staff
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Combination Products, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, January 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biological Products
Device Approval
Drug Approval
Government Regulation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- This guidance presents the current thinking of FDA on principles for premarket review of combination products. This guidance offers general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The remainder of this guidance focuses on how to determine which type of premarket submissions may be appropriate for combination products. The Agency has published guidance on premarket review issues relevant to specific categories of combination products and will continue to use such guidance as needed to provide more detailed information on specific premarket considerations and specific types 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 U.S.C. 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (23 pages)).
- NLM Unique ID:
- 9918351274006676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351274006676