Combination Products Guidance Documents
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More information and guidance can be located on the combination products website.
Current Good Manufacturing Practice Requirements for Combination Products
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)
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
- 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)
Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Minimal Manipulation of Structural Tissue (Jurisdictional Update)
Early Development Considerations for Innovative Combination Products
Application User Fees for Combination Products
Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product