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Combination Products
About Combination Products
Combination product definition, reports, examples and common questions.
Classification and Jurisdictional InformationProduct transfers, jurisdictional updates and public RFD decisions.
RFD ProcessRequest for Designation (RFD) submission information.
Guidance & Regulatory Information
Combination products rules, regulations, and guidance documents.
Requests for CommentCombination product documents for public comment.
Meetings, Conferences, & WorkshopsPresentations, articles and information about combination product meetings.
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Key Topics
- Combination Products Guidance Documents
- Guidance for Industry - New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)
- Postmarking Safety Reporting for Combination Products - Proposed Rule
- Current Good Manufacturing Practice Requirements for Combination Products - Proposed Rule
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Spotlight
- Guidance for Industry - New Contrast Imaging Indication Considerations for Devices and Approved Drug and Biological Products (PDF - 159KB)
- Postmarking Safety Reporting for Combination Products - Proposed Rule
- Current Good Manufacturing Practice Requirements for Combination Products - Proposed Rule
- Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products (PDF - 112KB)
- Article in Clinical Pharmacology & Therapeutics: Combination Products Regulation at the FDA
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Recalls & Alerts
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Approvals & Clearances
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Contact Us
Office of Combination Products
- (301) 427-1934
- (301) 427-1935 (Fax)
- combination@fda.gov
Food and Drug Administration
15800 Crabbs Branch Way (HFG-3)
Suite 200
Rockville, MD 20855
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