The FDA’s review process for medical devices still needs clarification, and the link between user fees and performance needs strengthening, representatives of medical device manufacturers testified at a public hearing.

The FDA held the public hearing in September before beginning its update of the Medical Device User Fee and Modernization Act (MDUFMA), which is up for renewal in 2012. The law imposes user fees on medical-device companies in order to provide the FDA with sufficient resources to review the safety of medical devices and approve them in a timely manner. The act was first passed in 2002, and it was renewed for a five-year period in 2007.

Dave Fisher, executive director of the Medical Imaging & Technology Alliance, says, “The general perception, among our members, is that the link between user fees and FDA performance is broken.” Medical-device companies provided nearly $300 million in user fees between 2008 and 2010 to help fund the program.

Review times for the 510(k) evaluation process have lengthened during the past several years, according to the Office of Device Evaluation’s 2009 Annual Performance Report. In 2005, the average total elapsed time from receipt to final decision was 87 days. By 2007, that figure had risen to a high of 117 days; it dropped to 98 days in 2009. Mark Leahey, president and CEO of the Medical Device Manufacturers Association, testified at the public hearing. He says, “I think 2005 was kind of the high-water mark, as far as performance goes, and since then, it has deteriorated a bit, in some areas.”

Continued on Imagingbiz.com