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 for Biologics Evaluation and Research (CBER)||
|Center for Drug Evaluation and Research (CDER)||
|Center for Devices and Radiological Health (CDRH)||
|Office of Combination Products||
|Office of Special Medical Programs||
- 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: email@example.com.
- 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