The past few years have brought about significant scientific advances in biotechnology, genomics, proteomics, and pharmaceuticals, giving rise to a new type of medical product—the combination product. Combination products comprise two or more drug, device, or biological components that are physically, biologically, or otherwise combined. Combination products can be packaged together or provided separately where both are required to achieve the intended use. The complete definition of combination products is available at the FDA's Web site. [5. http://www.fda.gov/oc/combination/definition.html (accessed October 2005).] Examples of combination products include drug-eluting stents, a glucose monitor/insulin pump, and a biologic fibrin sealant to help control bleeding in liver surgery.
Historically, the FDA had assigned regulatory authority for these components to three distinct centers—the Center for
Drug Evaluation and Research (CDER), the CDRH, and the Center for Biologies Evaluation and Research (CBER). This multicenter system faced much criticism, especially as more manufacturers with combination products began the "convoluted regulatory path to approval ...'' [6. Lewin N. Faster approvals seen for drug and device combination products. BBI Newsletter 2003; 26(9):247.] Concerns were raised about the management of the review process when two (or more) FDA centers have review responsibilities; the transparency, consistency, and predictability of the assignment process; and lack of clarity about which postmarket regulatory controls applied to combination products. [7. FDA, Overview of the Office of Combination Products, http://www.fda.gov/oc/ combination/overview.html (accessed October 2005).]
To address these concerns, a new OCP was created on December 24, 2002 as part of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002 [8. Department of Health and Human Services, Food and Drug Administration, 21 CFR Part 3. Assignment of Agency Component for Review of Premarket Applications. Final rule. Federal Register. Vol. 68, No. 120, Monday, June 23, 2003 http://www.fda.gov/oc/ combination/section204.html (accessed October 2005).]
Key responsibilities of the new office include:
• assign combination products to the most appropriate FDA center for review,
• ensure timely and effective premarket review of combination products, and
• ensure consistent and appropriate postmarket regulation of similar products.
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