Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

摘要

The US Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), regulates medical devices and radiation-emitting products. The 510(k) clearance process, also called premarket notification, has become a major component of the medical-device regulatory framework in the United States. In passing the Medical Device Amendments of 1976, Congress intended the 510(k) process to be a short-term expedient to facilitate the agencys formidable task of classifying all marketed devices according to risk, reviewing high-risk medical devices on the market at that time for safety and effectiveness, and facilitating the entry of new devices until classification and review processes were in place. Until then, medical devices generally had not undergone premarket review by the FDA. The 510(k) clearance process was established to permit new medical devices to be brought to market by demonstrating only that they were substantially equivalent to already currently marketed devices, which were referred to as predicates. In response to the FDAs request, IOM appointed the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. This report summarizes the committees review of the 510(k) clearance process, its conclusions on whether the process is protecting patients optimally and promoting innovation, and its recommendations.