-
Regulatory Information
-
Combination Products Guidance Documents
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
More information and guidance can be located on the combination products website.
-
Guidance Documents:
- 04/2009 Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 112KB)
- 09/2008 New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (Draft Guidance) (PDF - 125KB)
- 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
- 08/2005 How to Write a Request for Designation (RFD)
- 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- 09/2004 Current Good Manufacturing Practice for Combination Products (Draft Guidance)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
-
-
-