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 |