Combination Products Guidance Documents
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More information and guidance can be located on the combination products website.
Guidance Documents:
- Principles of Premarket Pathways for Combination Products -01/2022
- Requesting FDA Feedback on Combination Products - 12/2020
- Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted Under a BLA, NDA, or ANDA - 04/2020
- Bridging for Drug-Device and Biologic-Device Combination Products - 12/2019
- Postmarketing Safety Reporting for Combination Products - 07/2019
- Compliance Policy for Combination Product Postmarketing Safety Reporting - 04/2019
- Evaluation of Devices Used With Regenerative Medicine Advanced Therapies - 02/2019
- Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use - 10/2018
- How to Prepare a Pre-Request for Designation (Pre-RFD) - 02/2018
- Classification of Products as Drugs and Devices and Additional Product Classification Issues - 09/2017
- Current Good Manufacturing Practice for Combination Products - 01/2017
- Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development - 02/2016
- Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products - 06/2013
- Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 - 04/2013
- Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA - 01/2013
- How to Write a Request for Designation (RFD) - 04/2011
- New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products - 12/2009
- Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - 07/2007
- Early Development Considerations for Innovative Combination Products - 09/2006
- Application User Fees for Combination Products - 04/2005
- Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product - 05/2004