The Institute of Medicine, part of the National Academy of Sciences, issued a report on July 29, 2011, commissioned by the United States Food and Drug Administration (FDA), which recommended an overhaul in the process of medical device regulation. Specifically, the panel concluded that the current 510(k) clearance system is flawed. The Panel advised the FDA to completely redesign the medical device regulation process for medium risk devices, rather than merely tinkering with the 510(k) system.

Various stakeholders, including some in Congress and a coalition of major trade associations and medical device companies, have denounced the Panel's erroneous conclusion that the 510(k) does not evaluate safety and effectiveness and must therefore be replaced. Although FDA itself has stated that it will not eliminate the 510(k) process, the FDA also has stated that it is open to making changes to the process. Overall, the 510(k) process remains under attack and there could well be significant modifications to it.

Medical device manufacturers should monitor the FDA’s reaction to the Institute’s recommendations and should remain alert to changes to the 510(k) system. B&D Consulting professionals are monitoring developments and providing input, including developing formal comments, to FDA and members of Congress. Baker & Daniels LLP's professionals include both regulatory and product liability defense lawyers familiar with the 510(k) clearance process.