Regulatory Information
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Combination Products Guidance Documents
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More information and guidance can be located on the combination products website.
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Guidance Documents:
- 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)
- 04/2009
Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 112KB) - 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 - 09/2004
Current Good Manufacturing Practice for Combination Products (Draft Guidance) - 05/2004
Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product
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