An Overview of the US Regulatory Environment for Drug-Device and Biologic-Device Combination Products
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An Overview of the US Regulatory Environment for Drug-Device and BiologicDevice Combination Products The Food and Drug Administmtion (FDA) has for manyyearsfocused and identified its mission
Michael R. Hamrell, PhD, RAC President, MORIAH Consultants. Yorba Linda, California
Key Words Combination products; Background; Product jurisdiction Correspondence Address Michael R. Hamrell. PhD, MORJAH Consultants, 4481 Paloma Lane. Yorba Linda, CA 92886-2832.
regarding m e d i d products on tmditional dasses and uses for products. This legacy has contributed to a sometimes-confusing set of praiwct dassification precedents that are not alwajs s t r m g h q d or logid for the advanadptwducts under development. complicating this jbrther is the fact that, although one FDA center may have histm’d responsibility or legal juris-
The explosion of technological advances in the biomedical sciences has greatly enhanced the development of new products. Although these advances have been used to generate new products and new ways to use products, they have also created new challenges for the Food and Drug Administration (FDA). Specifically,the advances continue to challenge existing regulatory definitions developed for more traditional products, and they challenge the FDA to create new regulatory and jurisdictional approaches to regulated products. Nowhere is this more evident than in the current approach to combination products (1).
COMB I N AT1 0 N P R O D U CTS A N D APPROVAL Combination products, which combine two products in different regulatory categories (eg, device and biological product) into a single product, have long been a controversial and sensitive subject for the FDA. For many years, the agency’s various product centers disagreed about which center should regulate certain combination products. In some cases, the review and regulation of these combination products were divided or shared between the centers. Combination products were often regulated by the different centers on a case-by-case basis, a
diction over a product, the medical and technical expertise necessaryfor the review of that product may reside elsewhere within the agency. This article provides an ovm’ew of the history of the regulation of m e d i d products by the FDA, particulady for products that are a combination of two different and active components. It also describes some ofthe current initiatives and regulations that try to darifi the issues and regulatory status of this gravingclass of medical products.
situation that led to some degree of inconsistency. Later, the centers developed memoranda of understanding (MOU) to detail how they would regulate specific combination products that overlapped jurisdictional lines. Often, products not covered by the MOUs were handled through either unwritten agreements or negotiations between the centers. Another confounding factor in this area has been the constant change in the administrative and regulatory structure within the FDA. Biological products were regulated for many years by the Bureau of Biolog
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