January 19, 2011

The Food & Drug Administration released its plan of action for changes to its 510(k) medical device clearance program this morning.  The changes were highlighted in President Obama’s op-ed piece in yesterday’s Wall Street Journal.

Of the fifty-five changes to the 510(k) program that the FDA was proposing in August, twenty-five of the changes are to be implemented this year.  The FDA plans to hold off consideration of the more controversial changes until after the release of an Institute of Medicine report scheduled for this summer.

Some of the changes being implemented this year are designed to streamline the approval process, thereby fostering more innovation in medical devices.  Other changes are focused on improving patient safety.

Details of the changes being implemented can be found on the FDA’s web site:

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm