Annual Reports to Congress
FDA established the Office of Combination Products (OCP) on December 24, 2002, as required by MDUFMA. The mission of OCP is to ensure the prompt assignment of combination products (drug-device, biologic-device, drug-biologic, or drug-device-biologic products) to FDA Centers, the timely and effective premarket review of such combination products, and consistent and appropriate postmarket regulation of these products. MDUFMA also required that FDA submit an annual report to Congress on activities and impact of OCP. The following documents are OCP’s reports to Congress for each of the indicated fiscal years.