Combination Products
About Combination Products - What is a Combination Product? Learn more about combination products
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About Combination Products
Navigate the Combination Products Section
About Combination Products
Combination product definition, reports, examples and common questions.
Classification and Jurisdictional InformationProduct transfers, jurisdictional updates and public RFD decisions.
RFD ProcessRequest for Designation (RFD) submission information.
Guidance & Regulatory Information
Combination products rules, regulations, and guidance documents.
Feedback on Combination ProductsCombination product documents for public comment.
Meetings, Conferences, & WorkshopsPresentations, articles and information about combination product meetings.
Key Topics
Combination Products Guidance Documents - Guidance Document: Current Good Manufacturing Practice Requirements for Combination Products
- Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (PDF - 336KB)
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 New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)Combination Product Review Intercenter Consult Process Study (PDF - 299KB)Electronic Common Technical Document Technical Conformance Guide (added 10/5/2015) (PDF – 160KB) (PDF - 303KB)- Final Decision on Appeal for RFD 2009.0035 - Diphoterine Skin Wash (PDF - 1.1MB)
Industry Resources
RFD Process How to Prepare a Pre-Request for Designation (Pre-RFD) Jurisdictional Information - Final Rule: Current Good Manufacturing Practice Requirements for Combination Products
- Final rule on postmarketing safety requirements for combination products
- Webinar Slides: Final Rule on Postmarketing Safety Reporting (PDF - 187KB)
Reports and Data
Spotlight
- Final Guidance: Classification of Products as Drugs and Devices and Additional Product Classification Issues
Devices Referencing Drugs; Public Hearing; Request for Comments - Final rule on postmarketing safety requirements for combination products
- Webinar: Final Rule on Postmarketing Safety Reporting
How to Prepare a Pre-Request for Designation (Pre-RFD)
Policy Coordination
Contact FDA
Office of Combination Products
Food and Drug Administration
WO32, Hub/Mail Room #5129
10903 New Hampshire Avenue
Silver Spring, MD 20993