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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. 

CategoryTitleTypeDate
Pre-MarketCross-Center Master Files: Where to Submit | FDADraft11/2025
Pre-MarketHow to Prepare a Pre-Request for Designation (Pre-RFD)Final (revised)11/2025
Post-marketUnique Device Identifier Requirements for Combination ProductsDraft6/2025
Pre-marketApplication User Fees for Combination ProductsFinal (revised)7/2024
Pre-marketPurpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination ProductsDraft7/2024
Pre-marketEssential Drug Delivery Outputs (EDDO) for Devices Intended to Deliver Drugs and Biological Products Draft6/2024
Pre-marketRegulatory Considerations for Prescription Drug Use-Related SoftwareDraft9/2023
Pre-marketApplication of Human Factors Engineering Principles for Combination Products: Questions and AnswersFinal9/2023
Pre-marketPrinciples of Premarket Pathways for Combination ProductsFinal1/2022
Pre-marketRequesting Food and Drug Administration Feedback on Combination ProductsFinal12/2020
Pre-marketTechnical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDADraft4/2020
Pre-marketBridging for Drug-Device and Biologic-Device Combination Products Draft12/2019
Post-marketPostmarketing Safety Reporting for Combination ProductsFinal7/2019
Post-marketCompliance Policy for Combination Product Postmarketing Safety ReportingFinal4/2019
JurisdictionalHow to Prepare a Pre-Request for Designation (Pre-RFD)Final02/2018
JurisdictionalClassification of Products as Drugs and Devices and Additional Product Classification IssuesFinal09/2017
Post-marketCurrent Good Manufacturing Practice Requirements for Combination Products(PDF - 336KB)Final01/2017
Pre-marketTechnical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological ProductsFinal06/2013
Pre-marketGlass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4Draft04/2013
Post-marketSubmissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMADraft01/2013
JurisdictionalHow to Write a Request for Designation (RFD)Final04/2011
Pre-marketNew Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological ProductsFinal12/2009
JurisdictionalDevices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)Final07/2007
Pre-marketEarly Development Considerations for Innovative Combination ProductsFinal09/2006
Pre-marketApplication User Fees for Combination ProductsFinal04/2005
Pre-marketSubmission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination ProductFinal05/2004

 

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