The Institute of Medicine will release the highly anticipated results of its year-long investigation into the FDA’s medical device review process at the end of this week.
The IOM was tasked by the FDA to do a soup-to-nuts review of the program in late 2009 and many in the industry are fearful that the institute will call for sweeping changes and that the FDA will follow suit.
The FDA said earlier this month that it was "not bound" by the IOM’s recommendations, and that it "will consider them and make its own decisions," according to minutes of a June 17 meeting between medical device industry and agency officials.
FDA officials have said that they agree with industry that there are concerns over the total time it takes for medical devices to go through the 510(k) program and suggested that those expanding decision times should be addressed in the next user fee reauthorization. Officials said that, while they haven’t seen an increase in review time on their end, an examination of the 510(k) process found that increased total times were "driven by a combination of increasing numbers of cycles and increasing time Industry takes for each cycle."
For it’s part, the med tech industry doesn’t believe that to be the case and maintains that workloads have remained at the same levels. Further, industry contends that the FDA has essentially doubled the user fees over the lifetime of the program and has not met performance goals. During an early June meeting, industry proposed a two year stay at current levels (adjusted for inflation) because the agency had "not yet achieved" some of the qualitative and quantitative goals set when the user fee program was reauthorized in 2007.
The current medical device user fee act is set to expire in 2012. The user fees are supposed to make up for the FDA’s resource shortfall to help it review device applications more quickly and, ultimately, speed devices to market.