An Overview of the US Regulatory Environment for Drug-Device and Biologic-Device Combination Products

Abstract

The Food and Drug Administmtion (FDA) has for many years focused and identified its mission regarding medid 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 advanad ptwducts under development. complicating this jbrther is the fact that, although one FDA center may have histm'd responsibility or legal jurisMichael R. Hamrell, PhD, RAC Yorba Linda, California President, MORIAH Consultants.diction over a product, the medical and technical expertise necessary for 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 graving class of medical products.

Overview of the Regulation of Medical Devices and Drugs in the European Union and the United States

“…This review has demonstrated that the regulation of these products is extremely complex, which confirms the views of other commenters. 14,15 Each jurisdiction has its own regulatory framework with different legislation. Furthermore, there is a range of regulatory authorities involved, which adds to the complexity of the process.…”

Recent advances in dermal wound healing: biomedical device approaches

“…Three FDA centers regulate combination products: 'Biologics Evaluation and Research' (CBER), 'Devices and Radiological Health' (CDRH), and 'Drug Evaluation and Research' (CDER) [83]. Determining which center has jurisdiction is a major challenge, as many of the new products being developed do not fit neatly into existing regulatory categories.…”

Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review

“…The MDD process has been satisfactorily described in literature; however, there is a lack of comprehensive models that would support design teams with different experiences and backgrounds. In general, published studies in this area either address the MDD with a specific focus on regulations (9,13,14) or provide proposals for various approaches to MDD (9,15,16).…”