Combination Products Guidance Documents
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More information and guidance can be located on the combination products website.
Guidance Documents:
- 01/2017
How to Prepare a Pre-Request for Designation (Pre-RFD) - 01/2017
Current Good Manufacturing Practice Requirements for Combination Products - 02/2016
Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development (PDF - 336KB) - 06/2013
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 153KB) - 04/2013 Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4
- 01/2013 Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA (PDF - 101KB)
- 06/2011
Classification of Products as Drugs and Devices and Additional Product Classification Issues - 06/2011
Interpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act - 04/2011 How to Write a Request for Designation (RFD)
- 12/2009 New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)
- 07/2007
Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - 09/2006
Minimal Manipulation of Structural Tissue (Jurisdictional Update) - 09/2006
Early Development Considerations for Innovative Combination Products - 04/2005
Application User Fees for Combination Products - 05/2004
Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product