Most medical devices that are reviewed by the U.S. Food and Drug Administration before entering the marketplace are cleared for use in a process called premarket notification, or the 510(k) clearance process, named after a section of the 1976 law that authorized the process. Prompted by concerns that have been raised about whether the 510(k) clearance process is adequately protecting and promoting the public’s health, the FDA asked the IOM to convene a committee to evaluate the process and make recommendations aimed at protecting public health while preserving a mechanism to get new medical devices to market in a timely manner. The committee’s report, Medical Devices and the Public’s Health: The FDA’s 510(k) Clearance Process at 35 Years, will be available for immediate release at 9 a.m. EDT on Friday, July 29. The committee will discuss its findings and recommendations during a public briefing starting at 11 a.m. EDT on July 29 in Room 100 of the National Academies’ Keck Center, 500 Fifth St., N.W., Washington, D.C. A live video webcast of the briefing will be available at www.nas.edu/510kprocess.
To obtain a copy of the report or register to attend the briefing, contact the Office of News and Public Information; tel. 202-334-2138 or e-mail firstname.lastname@example.org. More information on the study is available at www.nas.edu/510kprocess.