On July 26, 2011, the FDA released a much anticipated revision to the medical device guidance document "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device." Although we are still analyzing the impact and comparing it to the prior 1997 device modification, one thing is clear: more 510(k)s are required under the new guidance terms. Over the next few weeks, we will analyze policy modifications related to changes in labeling, manufacturing processes, technology or engineering, and materials. In the meantime, if you are a member of the Regulatory Affairs Professional Society (RAPS), watch their blogs and discussion pages to learn how others view the new guidance. Soon after, on July 29, the long-awaited and much anticipated Institute of Medicine report on the 510(k) process was released. The FDA commissioned the report as part of the FDA’s 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making review process. The 510(k) Working Group recommendations caused quite a stir, but the FDA held off on implementing a number of key recommendations until this IOM report was released. Now, the report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” is finally out. In short, the IOM’s recommendation is to scrap the entire 510(k) program and start again. We are currently analyzing the entire report and following the FDA’s reactions. Subscribe to our blog to receive up-to-date analysis and participate in the discussion.
We expect a lot of commentary and questions from clients over the next few weeks as these major changes take hold and industry sorts out the details. Given the FDA’s less than enthusiastic reaction to the report, we thought August would be a good time to dig into a series of comparisons between device processes in the United States and those in the European Union. Stay tuned this week for the first in our series by guest blogger Charlotte Sellier.