I am pleased to submit the Food and Drug Administration’s (FDA’s) Fiscal Year (FY) 2008 Annual Report to Congress for the Office of Combination Products (OCP). This report includes the fifth full year of data since OCP was established as mandated by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA I), enacted on October 26, 2002.
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. FDA expects to receive large numbers of combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they raise challenging regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
OCP continues to enhance the transparency and predictability of the combination product lead Center assignment and review process. In this regard, OCP facilitates interactions between industry and FDA to clearly delineate regulatory paths, continues to monitor and adjust processes to ensure timely and effective review, and continues to ensure the consistent and appropriate postmarket regulation of combination products. In addition to combination products, OCP also has classification and assignment responsibilities for non-combination drug, device, and biologic products.
Combination products will likely become more complicated as new technologies emerge and existing technologies mature. Therefore, OCP will continue to focus on the most important issues relating to the regulation of combination products. OCP is committed to actively assisting industry and FDA reviewers in understanding this complex regulatory area. A major OCP accomplishment in FY 2008 was the issuance of draft guidance to clarify the regulatory pathway for medical imaging products as required by the Medical Device User Fee Amendments of 2007 (MDUFA II).
FDA looks forward to ensuring success in meeting the unique challenges in the review and regulation of combination products.
Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs