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 OCP broad responsibilities covering the regulatory life cycle of combination products. Specifically, the primary roles of OCP are:
- To serve as a focal point for combination product issues for FDA staff and industry.
- To develop guidance, regulations, and standard operating procedures to clarify the regulation of combination products.
- To classify products as drugs, devices, biological products, or combination products and assign an FDA center to have primary jurisdiction for premarket review and postmarket regulation 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 facilitate resolution of 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 develop annual reports to Congress on the Office’s activities and impacts.
- To provide training to FDA staff and regulated industry on combination product regulation.
The Office of Combination Products currently has 14 staff members:
- Thinh Nguyen - Director
- Patricia Love, MD, MBA - Deputy Director
- John (Barr) Weiner, JD - Associate Director for Policy and Product Classification Officer
- Leigh Hayes, JD - Lead Product Jurisdiction Officer
- Jose Moreno, PhD - Senior Scientific Reviewer
- Joseph Milone, PhD - Senior Scientific Reviewer
- Bibi Jakrali - Management Analyst
- Bindi Nikhar, MD - Associate Clinical Director
- Melissa Burns - Senior Program Manager
- Diana Yoon, PhD - Senior Scientific Reviewer
- Maryam Mokhtarzadeh, MD - Senior Medical Officer
- Stephanie Shapley MBA - Senior Health Scientist
- Danita Dixon - Project Management Officer
- Lauren Bateman - Project Manager
All inquiries should be sent to OCP’s central inbox, email@example.com. This inbox is monitored during business hours and your inquiry will be assigned to the appropriate OCP staff member for response.
- Combination Products
- Combination Products Guidance Documents
- RFD Process
- Combination Products Performance Reports
- Office of Combination Products
Office of Clinical Policy and Programs
Food and Drug Administration
10903 New Hampshire Ave WO32-5129
Silver Spring, MD 20993