Food And Drug Administration Regulates Medical Devices

Earl Bakken believed in the "ready, fire, aim" method of device development, which was symbolic of the approach in which devices were actually tested in humans; therefore, the transition from bench to bedside was at an accelerated pace (5). However, dramatic changes in the regulation of medical device development and use since 1976 have played an important role in the number and types of devices manufactured, as well as the safety of these devices, before clinical use.

In 1976, the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act established three regulatory classes for medical devices based on the degree of control necessary to ensure the safety and effectiveness of various types of devices. The most regulated class is class III devices, which are designed to support or sustain human life or are of substantial importance in preventing impairment of human health or present a potential unreasonable risk of illness or injury. All devices placed in class III are subject to premarket approval requirements, including a scientific review, to ensure their safety and effectiveness.

Under Medical Device Reporting in the Food and Drug Administration (FDA), all manufacturers, importers, and user facilities are required to report adverse events and to correct them quickly. Although, since 1984, manufacturers and importers of medical devices have been required to report all device-related deaths, serious injuries, and certain malfunctions to the FDA, numerous reports show underreporting. Therefore, the Safe Medical Devices Act (SMDA) of 1990 was implemented; device user facilities must report device-related deaths to the FDA and the manufacturer. In addition, the SMDA requires that device user facilities submit reports to the FDA on an annual basis (FDA Modernization Act of 1998). In spite of this strict regulatory environment, Minnesota has continued to be a leading state for design, licensing, and manufacture of medical devices.

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Essentials of Human Physiology

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