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About Combination Products

About Combination Products

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.

Refer to the links at the left of this page for more information about combination products.


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Contact Us

Contact Point

(301) 796-8930
Fax
Fax: (301) 847-8619

Hours Available

Office of Combination Products
Office of Special Medical Programs
Food and Drug Administration

10903 New Hampshire Ave WO32-5129

Silver Spring, MD 20993
United States