Combination Products

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. 

Post-marketPostmarketing Safety Reporting for Combination ProductsDraft 3/2018
Post-marketCompliance Policy for Combination Product Postmarketing Safety ReportingFinal3/2018
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-marketHuman Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development(PDF - 336KB)Draft02/2016
Pre-marketTechnical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 153KB)Final06/2013
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 PMA (PDF - 101KB)Draft01/2013
JurisdictionalInterpretation of the Term "Chemical Action" in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic ActDraft06/2011
JurisdictionalHow to Write a Request for Designation (RFD)Final04/2011
Pre-marketNew Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)Final12/2009
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


Page Last Updated: 03/19/2018
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