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 InformationJurisdictional Information for human medical products
RFD ProcessInformation on the RFD Process, including how to write a Request for Designation and a Pre-Request for Designation
Guidance & Regulatory Information
Combination products rules, regulations, and guidance documents.
Feedback on Combination ProductsDetails on how to leave feedback with the Office of Combination Products
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- Draft Guidance: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (PDF - 336KB)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 - 363KB)- Final Decision on Appeal for RFD 2009.0035 - Diphoterine Skin Wash (PDF - 1.1MB)
Industry Resources
Postmarketing Safety Reporting for Combination Products RFD Process How to Prepare a Pre-Request for Designation (Pre-RFD) Jurisdictional Information - Final Rule: Current Good Manufacturing Practice Requirements for Combination Products
Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff (PDF - 198KB)
Reports and Data
Spotlight
- Proposed List of Alternative or Streamlined Mechanisms for Complying with the CGMP requirements for Combination Products
- Proposed Rule to amend Part 3 on Product Classification and Assignment
Postmarketing Safety Reporting for Combination Products - How to Prepare a Pre-Request for Designation (Pre-RFD), Final Guidance
- Final Guidance: Classification of Products as Drugs and Devices and Additional Product Classification Issues
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