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What physicians should know about the regulation of Obstetric and Gynecologic Medical Devices.


 This article provides background and discusses the purposes of the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act of 1976, which gave the Food and Drug Administration (FDA) the responsibility of protecting the public from unsafe and ineffective medical devices. The FDA is authorized to ensure that devices are safe and effective both before and during marketing, and must classify all medical devices for human use into 1 of 3 regulatory categories based on the extent of control necessary to assure their safety and effectiveness: Class I, General Controls; Class II, Performance Standards, and Class III, Premarket Approval. Panels of experts including 1 nonvoting representative each of industry and consumers will continue until all devices are classified. Device manufacturers are required to register and list their products, and there is a premarket notification requirement applicable to manufacturers of all postamendment devices. Under certain circumstances the FDA is authorized to ban devices, order manufacturers, importers, or distributors to repair or replace devices presenting unreasonable health risks, or restrict the sale, distribution, or use of a device. The FDA promulgates regulations requiring conformity with good manufacturing practice regulations and can regulate color additives and develop performance standards for Class II devices. The development of a device and collection of data necessary to demonstrate safety and effectiveness may occur simultaneously, in which case a Product Development Protocol must be submitted to the FDA. Devices intended solely for investigational use and custom devices may be exempt from some requirements. In most cases the amendments preempt state and local requirements. Imported devices must comply with FDA regulations. The Office of Small Manufacturers Assistance has been established to assist small manufacturers in complying with the act. Greater cooperation with medical practitioners would be highly desirable in the regulation of medical devices.
