Part I    Introduction    Definitions    Overview    History    The FDA    Appendix    Figures    History Table    References Part II Part III Regulatory Articles

State of the Art Primer on Medical Device Regulation Part I - History and Background1 Lee H. Monsein Introduction Before the 1930s, the medical device industry was practically nonexistent. Many medical devices were sold directly to the public. With the explosion of medical technology after World War II, several intermediaries evolved between the medical device industry and the public. Various local, state, and federal Abbreviations: CBER = Center for Biologics Evaluation and Research CDER = Center for Drug Evaluation and Research CDRH = Center for Devices and Radiological Health CFR = Code of Federal Regulations DHEW = Department of Health, Education and Welfare DHHS = Department of Health and Human Services FDA = Food and Drug Administration FD&C = Food, Drug and Cosmetic PHS = Public Health Service USC = United States Code regulatory agencies are now ultimately responsible for the medical technology that reaches consumers. It therefore behooves physicians and health care providers to be knowledgeable about medical device regulation. The following review draws on a number of recent essays on the subject (1-5). This article is the first of a three-part series reviewing medical device regulation. Part I provides an overview and history of medical device regulation and the U.S. Food and Drug Administration (FDA) and discusses government document nomenclature (Fig 1). Part II details current medical device regulation. Part III describes regulatory mechanisms and enforcement of medical device regulation. It also reviews the regulation of imported and exported medical devices, as well as foreign medical device regulation. Radiology 1997; 205:1-9 Index terms: Radiology and radiologists State-of-art reviews U.S. Food and Drug Administration 1 From the Department of Radiology, Washington Hospital Center, 110 Irving St NW, #BA60, Washington, DC 20010-2975. Received March 27, 1997; revision requested May 19; revision received June 4; accepted June 9. Address reprint requests to the author. ©RSNA, 1997 Sections of this article Introduction (this page) DEFINITIONS (next) OVERVIEW OF MEDICAL DEVICE REGULATION HISTORY OF MEDICAL DEVICE REGULATION THE FDA APPENDIX: PRINCIPLES OF GOVERNMENT DOCUMENT NOMENCLATURE