FDA Giving the Opportunity to Comment on Possible Changes to the 510(k) Process

Aug 17, 2011   
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On August 12, 2011, the U.S. Food and Drug Administration (FDA) announced its plans to hold a public meeting, where it will elicit comments from the public concerning the proposed changes to its 510(k) process. The meeting, which will be held next month, will focus primarily on the recommendations proposed in the recent report by the Institute of Medicine (IOM).

Currently, the 510(k) process is the means by which most medical devices are cleared by the FDA in order to be brought to market. While this process has remained relatively unchanged over the last three decades, there has been much attention over the past year of reforming it. As we previously reported, the plans to overhaul the system have been in the works since 2009. However, efforts to revamp the process have gained momentum only recently.

As we recently reported, IOM released its proposed recommendations on updating the 510(k) system. Found here, the report contains a number of changes that IOM suggests could help FDA ensure that medical devices are safer for the public. Because the IOM report suggests significant changes to the 510(k) process, including a total abandonment of the way the process currently operates, FDA is seeking public comment concerning these recommendations.

Fuerst Ittleman will continue to monitor the developments and changes to 510(k) premarket notification process. For more information, please contact us at contact@fidjlaw.com.