Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation. Workshop Report

摘要

At the request of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) has convened a consensus committee to review the 510(k) clearance process for medical devices. Also known as premarket notification, the process in Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already on the market, in which case the device does not need to go through the premarket approval process. The current 510(k) process, as written in statute and implemented by FDA, is intended to meet two primary goals: (1) to make safe and effective devices available to consumers and (2) to promote innovation in the medical device industry. Concern has been raised, however, that the 510(k) process permits inadequately tested devices to reach the market and thereby places the health of patients at risk.