Combination Products

Therapeutic and diagnostic products that combine drugs, devices, and/or biological products.

Topic Paragraphs

A person prepares to use a generic auto-injector to give themself a drug dose

About Combination Products

Combination product definition, reports, examples and common questions.

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Guidance & Regulatory Information

Combination products rules, regulations, and guidance documents.

Classification and Jurisdictional Information

Jurisdictional information for human medical products.

Feedback on Combination Products

Details on how to leave feedback with the Office of Combination Products.

Meetings, Conferences, & Workshops

Presentations, articles and information about combination product meetings.

Combination Products Guidance Documents Informaton on the RFD Process

Current Good Manufacturing Practice Requirements for Combination Products

Classification of Products as Drugs and Devices and Additional Product Classifi…

How to Prepare a Pre-Request for Designation (Pre-RFD)

Postmarketing Safety Reporting for Combination Products

Frequently Asked Questions About Combination Products

Information About the Office of Combination Products

Combination Product Definition and Combination Product Types

Combination Product Contacts

Combination Products Performance Reports

Combination Products Policy Council

Acts, Rules and Regulations

Contact Us

[email protected]

(301) 796-8930

Fax

Fax: (301) 847-8619

Hours Available

Office of Combination Products

U.S. Food and Drug Administration