Combination Products

Combination Products Policy Council

About Us

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/OfficeParticipants
Center for Biologics Evaluation and Research (CBER)
  • Center Director or designee
  • Center representative
Center for Drug Evaluation and Research (CDER)
  • Center Director or designee
  • Center representative
Center for Devices and Radiological Health (CDRH)
  • Center Director or designee
  • Center representative
Office of Combination Products
  • Office Director or designee
Office 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.

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Page Last Updated: 01/18/2017
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