Combination Products
Office of Combination Products Relocation
The Office of Combination Products (OCP) has moved to the FDA White Oak Campus. As of Monday, April 19, 2010, OCP has new contact information (below at right).
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.
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.
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
Spotlight
FY 2008 OCP Performance Report 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)
Recalls & Alerts
Approvals & Clearances
Contact Us
Office of Combination Products
- 301-796-8930
- Fax:
301-847-8619 - combination@fda.gov
Food and Drug Administration
WO32, Hub/Mail Room #5129
10903 New Hampshire Avenue
Silver Spring, MD 20993