On Dec. 24, 2002, the U.S. Food and Drug Administration’s (FDA) Office of Combination Products (OCP) was formed within the Office of the Commissioner, as mandated under the Medical Device User Fee and Modernization Act, to oversee review of products that fall into multiple jurisdictions within FDA.

The OCP assigns combination products to the FDA’s medical product centers for review, helps coordinate timely, effective and aligned reviews of combination products and oversees the postmarket activities of combination products to help ensure their safety and quality in order to protect patients from harm.

The OCP:

• Serve as primary point of contact for combination product issues for FDA staff and industry.
• Develop guidance, regulations and standard operating procedures to clarify combination product regulation.
• Classify products as drugs, devices, biological products or combination products and assign an FDA center for premarket review and postmarket safety oversight.
• Ensure timely and effective review of combination products by overseeing and coordinating reviews involving more than one FDA center.
• Oversee postmarket safety to protect patients from potential health risks associated with combination products currently on the market.
• Facilitate dispute resolution regarding the timeliness of premarket review of combination products.
• Update agreements, guidance documents or practices specific to assigning combination products.
• Develop annual reports to Congress on the office’s activities and impacts.
• Provide training to FDA staff and regulated industry on combination product regulation.