In the News

Institute of Medicine to Study FDA's Premarket Notification Program for Medical Devices

Oct 15, 2009

The U.S. Food and Drug Administration (FDA) has commissioned the Institute of Medicine (IOM) to study the premarket notification (PMN) program, also called the 510(k) process, used to review and clear certain medical devices marketed in the United States. IOM is scheduled to publish its conclusions and recommendations in March 2011. In addition, FDA's Center for Devices and Radiological Health (CDRH) will establish an internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process, and will recommend interim changes that can be made prior to the completion of the IOM study.

The 510(k) process, named after Section 510(k), was established under the Medical Device Amendments of 1976, which modified the Federal Food, Drug, and Cosmetic Act to authorize FDA to review new medical devices. Prior to marketing a new medical device in the U.S., manufacturers are required to submit either a Premarket Application (PMA), or a PMN to FDA unless the device is exempt. A 510(k) needs to demonstrate that the device is substantially equivalent to a legally marketed device that is not subject to premarket approval (PMA). (More information on PMN of medical devices can be found on the FDA website.)

An independent review of the 510(k) program was one of the recommendations in a FDA report on the agency's review and clearance of a medical device manufactured by Hackensack, NJ-based ReGen Biologics, Inc. The device, ReGen Menaflex, is used in treating knee injuries. The report identifies departures from standard processes, procedures, and practices that compromised the review process. In particular, the report suggests that external pressure may have distorted the Office of Device Evaluation (ODE) Director's decision-making process. The device received FDA clearance in December 2009 after four New Jersey lawmakers intervened on the company's behalf.