THE NATIONAL ACADEMIES
Institute of Medicine
Board on Population Health and Public Health Practice
Committee on the Public Health Effectiveness of the FDA 510 (k) Clearance Process
Medical Devices and the Public's Health:
The FDA 510(k) Clearance Process at 35 Years
At the request of the Food and Drug Administration, the Institute of Medicine examined the 510(k) clearance process, which requires device manufacturers to demonstrate that their new product is substantially equivalent to an already approved device. This report looks at that process, evaluating whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process.
These series of briefings were for members of Congress and congressional staff only. The report was publicly released on July 28, 2011 and can be found, in its entirety, on the .