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 In this section:

                About Combination Products

About Combination Products

                        Combination Product Definition Combination Product Types
          Combination Products Policy Council
          Frequently Asked Questions About Combination Products Home
          Combination Products
          About Combination Products
          Combination Products Policy CouncilAbout Combination Products Combination Products Policy Council
  
  	
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The Combination Products Policy Council provides a senior-level forum to establish combination product policy across the FDA and ensures that policy is implemented in a consistent manner throughout the Agency.

The Council is chaired by the Deputy Commissioner for Medical Products and Tobacco (OMPT) or his/her designee, comprised of the following members (see table below), and supported by an Executive Secretary. Council members include:Combination Products Policy Council Representation

**Center/Office**
			**Participants**Center for Biologics Evaluation and Research (CBER)
			Center Director or designee
				Center representativeCenter for Drug Evaluation and Research (CDER)
			Center Director or designee
				Center representativeCenter for Devices and Radiological Health (CDRH)
			Center Director or designee
				Center representativeOffice of Combination Products
			Office Director or designeeOffice of Special Medical Programs
			Office Director or designee

The Council will prospectively identify regulatory and scientific policy issues to address and function as a forum for developing guiding principles related to combination products, cross-labeled products, and medical product classification.
	The Council will resolve disagreements among Centers, the Office of Combination Products (OCP), and/or sponsors on activities and policies related to medical product classification and the clearance/approval of combination products and cross-labeled products. The Council does not meet directly with sponsors.For more information about the Council, please reach out to: combinationproductcouncil@fda.hhs.gov.

What’s New?

SMG4101: Inter-Center Consult Request Process
	SMG4103: Expectations and Procedures for Engagement Among Medical Product Centers and Office of Combination Products on Regulations and Guidance Pertaining to Combination Products
	Developing a Consensus Voice: The Combination Products Policy Council
	Combination Products Policy Council Charter
	‘Leaning in’ on Combination Products
	Piloting an Improved Intercenter Consult Process
	Making Continuous Improvements in the Combination Products Program: Pre-RFD Process
	Combination Products Review Program: Progress and Potential
	Docket for Combination Product Policy Council

                                                                                  Content current as of:
      06/18/2019About Combination Products

          
                        Combination Product Definition Combination Product Types
          Combination Products Policy Council
          Frequently Asked Questions About Combination Products
 
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