Combination Products
Combination Product Definition - What is a Combination Product? Read the FDA's definition now.
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Combination Product Definition
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.
Requests for CommentCombination product documents for public comment.
Meetings, Conferences, & WorkshopsPresentations, articles and information about combination product meetings.
Key Topics
Combination Products Guidance Documents Electronic Common Technical Document Technical Conformance Guide (added 10/5/2015) (PDF – 160KB) (PDF - 303KB)New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)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 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 - 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
Webinar: Combination Product CGMP Final Rule (Jan. 24, 2013) Homologous Use of Human Cells, Tissue, and Cellular and Tissue-Based Products; Draft guidance for Industry and FDA Staff (PDF - 120KB)
Spotlight
- Final rule on postmarketing safety requirements for combination products
- Webinar on Final Rule on Postmarketing Safety Reporting (PMSR) for Combination Products
- 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- Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (PDF - 336KB)
Combination Product Review Intercenter Consult Process Study (PDF - 299KB)
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