The FDA Office of Combination Products (OCP) was established on Dec. 24, 2002, as required by SEC. 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The law gives the Office broad responsibilities covering the regulatory life cycle of drug-device, drug-biologic, and device-biologic combination products. Specifically, the roles of OCP are:
- To serve as a focal point for combination product issues for agency reviewers and industry.
- To develop guidance and regulations to clarify the regulation of combination products.
- To assign an FDA center to have primary jurisdiction for review of both combination and single entity (i.e., non-combination) products where the jurisdiction is unclear or in dispute.
- To ensure timely and effective premarket review of combination products by overseeing the timeliness of and coordinating reviews involving more than one agency center.
- To ensure consistency and appropriateness of postmarket regulation of combination products.
- To resolve disputes regarding the timeliness of premarket review of combination products.
- To update agreements, guidance documents, or practices specific to the assignment of combination products.
- To submit annual reports to Congress on the Office’s activities and impacts.
The Office of Combination Products currently has 9 staff members:
- Thinh X. Nguyen - Director
- Patricia Y. Love, MD., MBA. - Deputy Director
- John (Barr) Weiner, JD. - Associate Director for Policy and Product Classification Officer
- Bindi Nikhar, MD. - Associate Clinical Director
- Leigh Hayes, J.D. - Senior Regulatory Council for Product Jurisdiction/Product Assignment Officer
- Joseph Milone, Ph.D. - Senior Scientific Reviewer
- Jose L. Moreno, Ph.D. - Senior Scientific Reviewer
- Melissa Burns - Senior Program Manager
- Bibi K. Jakrali - Management Analyst