FDA ESTABLISHES OFFICE OF COMBINATION PRODUCTS

The Food and Drug Administration has established a new office to streamline the processing of complex drug-device, drug-biologic, and device-biologic combination products that play an increasingly significant role in health care.

The new Office of Combination Products (OCP) will be part of the Office of the Commissioner, and its responsibilities will cover the entire regulatory life cycle of combination products, including jurisdiction decisions as well as the timeliness and effectiveness of pre-market review, and the consistency and appropriateness of post-market regulation. The primary regulatory responsibilities for, and oversight of, specific combination products will remain in one of three product centers -- the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health -- to which they are assigned.

"This is a significant step to increase the efficiency and timeliness of the procedures that make these important products available to patients," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "I also believe that the activities of this new office will help provide insights into how the Commissioner's office can better support a range of issues that cut across the three product centers, and thus bring greater uniformity and coherence to our processes."

The establishment of OCP is part of the FDA's implementation of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). The statutorily mandated functions of OCP are to:

1. promptly assign a center with primary jurisdiction for a combination product;
2. ensure the timely and effective premarket review of combination products, by overseeing the timeliness of and coordinating reviews involving more than one center;
3. ensure the consistency and appropriateness of postmarket regulation of combination products;
4. resolve disputes regarding the timeliness of premarket review of combination products;
5. review and modify, revise, (or eliminate if appropriate), agreements, guidance documents or practices specific to the assignment of combination products; and
6. submit annual reports to Congress on the activities and impact of the Office.

In addition, OCP will assume and continue the functions of the Combination Products Program established earlier this year within the Office of the Ombudsman. These functions include working with the centers to develop guidance and/or regulations to clarify the agency's regulation of combination products.

The new office will be headed by Mark Kramer, currently the Director of the Combination Products Program within the Office of the Ombudsman.

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