IOM Hosts 3rd Public Workshop on 510(k) Process

The Institute of Medicine (IOM) recently hosted its 3rd public workshop in Washington, DC to discuss the 510(k) review process and what potential changes may be needed.

There were several presentations, including one by Ralph Hall of the University of Minnesota Law School, who discussed his study of FDA recall data for 510(k) approved products. His study found that very few 510(k) clearances have been subject to a Class I recall, and in fact only about 0.45% of submitted products were recalled. He further found that there was no statistically significant difference in the number of 510(k) and PMA device recalls.

Mark Leahey, President and CEO of MDMA, attended the event, and MDMA staff has been working closely with the IOM and other leaders to ensure our members' concerns are heard.