Medical Devices and Health — Creating a New Regulatory Framework for Moderate-Risk Devices

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Abstract
The recently released Institute of Medicine (IOM) report Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years recommends that the Food and Drug Administration (FDA) begin to develop a new regulatory framework for moderate-risk (class II) medical devices.1 Regulation of devices began in 1938, and the regulatory structure reflected the relative simplicity of the devices that were on the market at that time. By the 1970s, the original regulatory framework was no longer adequate or flexible enough to deal with the growing array of device types and the increasing sophistication of new devices. Sporadic public health disasters associated with a few devices generated substantial public concern. Consequently, Congress passed the Medical Device Amendments of 1976,2 which established the framework for the current system. In 1990 and 1997, Congress enacted significant changes to the original statute.3

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