Office of Combination Products

Overview of the
Office of Combination  Products

Definition of a Combination Product

Frequently Asked Questions

Product Jurisdiction/Assignment of Combination Products:

• Guidance for Industry and FDA Staff:  How to Write a Request for Designation (RFD) [PDF 79KB] (August 2005)
• Assignment of Combination Products/Product Jurisdiction Program - Final Rule (June 23, 2003 )
• Jurisdictional Updates
  • Jurisdictional Update: Breath Test Combination Products (September 2006)
  • Minimal Manipulation of Structural Tissue [PDF 49KB] (September 2006)
    
  • Heparin Catheter Lock-Flush Solutions: Transfer from CDER to CDRH [PDF 51KB] (August 17, 2006 )
  • Jurisdictional Update: Drug – Device Combination Catheter Lock / Flush Solutions
  • Redacted Agency Decisions on Requests for Designations (Updated February 2007)
  • Intercenter Agreements
    (Updated September 2006)
  • Metered Dose Inhalers, Spacers and Other Accessories (September 2005)
  • Jurisdictional Determinations -- (Updated September 2006)
  • Drug-Biologic Combination Products
  • Human Demineralized Bone Matrix
  • Drug-Eluting Cardiovascular Stents
  • Dental Prophylaxis Pastes with Drug Components
• Transfer of Therapeutic Biological Products to the Center for Drug Evaluation and Research -- Revised Dec. 16, 2005
• Intercenter Agreements -- Revised Sept. 6, 2005
• Other Types of Combinations of FDA Regulated Products
• FY07 OCP Review Performance: Formal Requests for Designation Submitted by Industry (October 1, 2006 – September 30, 2007) (Updated February 2008)

Requests for Comments

• Review of Agreements, Guidances, and Practices in Compliance with the Medical Device User Fee and Modernization Act of 2002 [PDF 72KB] (September 2006)
• Request for Comments:
  • Adverse Event Reporting
  • Number of Marketing Applications for Combination Products (September 2005)

Guidance Documents and Procedures

• Guidance for Industry and FDA Staff: Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P’s) (July 2007)
• Minimal Manipulation of Structural Tissue [PDF 49KB] (September 2006)
• Guidance for Industry and FDA Staff: Early Development Considerations for Innovative Combination Products [PDF 130KB] (September 2006)
• Plans for Proposed Rulemaking on Good Manufacturing Practice and Postmarket Safety Reporting for Combination Products [PDF 39KB] (April 2006)
• Guidance for Industry and FDA Staff:  How to Write a Request for Designation (RFD) [PDF 79KB] (August 2005)
• Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products [PDF 302KB] (September 2004)
• Guidance for Industry and FDA Staff: Application User Fees for Combination Products [PDF 83KB] (April 2005)
• Guidance for Industry and FDA Staff: Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product [PDF 68KB]
• Selected Guidance Documents Applicable to Combination Products.
• Intercenter Consultative/Collaborative Review Process [PDF 82KB] HTML

Reports, Workshops and Presentations

• Report to Congress - Office of Combination Products Performance Report for 2007 [PDF 1.43 MB]]
• Report to Congress - Office of Combination Products Performance Report for 2006 [PDF 461KB]
• Article in Regulatory Affairs Focus Magazine: Combination Products: Challenges and Progress [PDF 1.83MB] (August 2005)
• Editorial in Journal of Medical Device Regulation: FDA's Office of Combination Products: Roles, Progress & Challenges [PDF 60KB] (August 2005)
• FDA/DIA Cross Labeling Workshop on May 10, 2005: Combination Products and Mutually Conforming Labeling: Federal Register Notice , Agenda and Presentations and Transcript of Workshop
• Report to Congress - Office of Combination Products Performance Report for 2005 [PDF 294KB]
• Recent Article in Silver Sheet: FDA Refines Premarket, GMP Paths for Combination Products [PDF 289KB] (November 2004)
• Recent OCP Presentations
• Recent Article in Medical Device & Diagnostic Industry Magazine: Forging New Regulatory Pathways at FDA
• Office of Combination Products: Annual Report to Congress[ PDF 251KB] HTML
• Progress Reports to Stakeholders
• Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical and Regulatory Challenges: Summary of FDA Workshop (July 8, 2003)
• November 25, 2002 Public Hearing on Regulation of Combination Products
  • Federal Register Notice
  • Agenda and Presentations
  • Transcript of Nov. 25, 2002 Public Hearing -[ PDF 213KB] HTML
• Regulation of Combination Products: FDA Employee Perspectives
  [PDF 74KB] [HTML]

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