FY 2011 OCP Performance Report
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Technological advances continue to merge product types and blur the historical lines of separation between FDA’s human 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 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 pre-clinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, user fees, 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 continues to facilitate interactions between industry and FDA to clearly delineate regulatory paths, monitor and adjust processes to ensure timely and effective review, and 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 are likely to 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 the complexities of this regulatory area.
A major OCP accomplishment in FY 2011 was the issuance of two related draft guidance documents: Draft Guidance for Industry and FDA Staff – Classification of Products as Drugs and Devices and Additional Product Classification Issues and Draft Guidance for Industry and FDA Staff – Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. We believe these guidance documents will provide industry with a clear understanding of FDA’s classification process.
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