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  1. Guidance & Regulatory Information

Combination Products Guidance Documents

The Office of Combination Products (OCP) develops cross-cutting FDA guidance for product classification, jurisdiction and combination products.  Product-specific guidance provided by each of the three FDA Centers that review combination products (CBER, CDER and CDRH), is also available. 

Category Title Type Date
Pre-market Application User Fees for Combination Products Final (revised) 7/2024
Pre-market Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products Draft 7/2024
Pre-market Essential Drug Delivery Outputs (EDDO) for Devices Intended to Deliver Drugs and Biological Products  Draft 6/2024
Pre-market Regulatory Considerations for Prescription Drug Use-Related Software Draft 9/2023
Pre-market Application of Human Factors Engineering Principles for Combination Products: Questions and Answers Final 9/2023
Pre-market Principles of Premarket Pathways for Combination Products Final 1/2022
Pre-market Requesting Food and Drug Administration Feedback on Combination Products Final 12/2020
Pre-market Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA Draft 4/2020
Pre-market Bridging for Drug-Device and Biologic-Device Combination Products  Draft 12/2019
Post-market Postmarketing Safety Reporting for Combination Products Final 7/2019
Post-market Compliance Policy for Combination Product Postmarketing Safety Reporting Final 4/2019
Jurisdictional How to Prepare a Pre-Request for Designation (Pre-RFD) Final 02/2018
Jurisdictional Classification of Products as Drugs and Devices and Additional Product Classification Issues Final 09/2017
Post-market Current Good Manufacturing Practice Requirements for Combination Products(PDF - 336KB) Final 01/2017
Pre-market Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products Final 06/2013
Pre-market Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 Draft 04/2013
Post-market Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Draft 01/2013
Jurisdictional How to Write a Request for Designation (RFD) Final 04/2011
Pre-market New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products Final 12/2009
Jurisdictional Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Final 07/2007
Pre-market Early Development Considerations for Innovative Combination Products Final 09/2006
Pre-market Application User Fees for Combination Products Final 04/2005
Pre-market Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product Final 05/2004

 

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