The Medical Device User Fee and Modernization Act (MDUFMA) requires the HHS Secretary to submit an annual report to Congress on the activities and impact of the Office of Combination Products (OCP). The report focuses on OCP’s efforts to ensure the prompt assignment of combination products to agency centers, timely and effective premarket review of such products, and consistent and appropriate postmarket regulation of combination products.

These reports are prepared by FDA’s Office of Combination Products in collaboration with the Office of Planning, Evaluation and Risk Management, the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.

For additional information on these reports, please contact:

Office of Planning, Evaluation and Risk Management
Food and Drug Administration
10903 New Hampshire Avenue
Building 1, Room 4300
Silver Spring, Maryland 20993-0002

Phone: 301-796-4850

FAX: 301-847-3541

For additional information on Combination products, please go to FDA’s Office of Combination Products.

Reports from previous years can be found in the FDA Archive.