- What is a Combination Product? Read the FDA's definition now.
Navigate the Combination Products Section
Combination product definition, reports, examples and common questions.Classification and Jurisdictional Information
Product transfers, jurisdictional updates and public RFD decisions.RFD Process
Request for Designation (RFD) submission information.
Combination Products Guidance Documents Guidance for Industry - New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products(PDF - 159KB) Postmarking Safety Reporting for Combination Products - Proposed Rule Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products(PDF - 153KB) Classification of Products as Drugs and Devices and Additional Product Classification Issues Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products(PDF - 153KB) Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 - Draft Guidance for Industry and FDA Staff(PDF - 98KB) Final Rule: Current Good Manufacturing Practice Requirements for Combination Products Webinar: Combination Product CGMP Final Rule (Jan. 24, 2013)
- Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA (PDF - 101KB)