Washington, DC -
02/15/2012 - The U.S. House Energy and Commerce subcommittee on health today held a hearing on the reauthorization of the Medical Device User Fee Act (MDUFA), which allows the U.S. Food and Drug Administration (FDA) to collect fees from medical device companies and use them to review and evaluate new devices in a timely fashion. Allan Coukell, director of medical programs at the Pew Health Group, issued the following statement about the hearing:
“We applaud the FDA and the medical device industry for reaching an agreement that will spur the innovation of new therapies for improving health and saving lives. We urge Congress to include MDUFA in this year’s user-fee reauthorization package.
“In addition, as part of MDUFA, Congress can streamline the process for reviewing innovative low- and moderate-risk devices. Reforms in this area would benefit both manufacturers and patients.
“Congress also can strengthen FDA’s ability to ensure that devices in the marketplace meet appropriate safety standards, per the recommendation of the Institute of Medicine. Many medical devices go to market without the clinical data that would allow us to confidently gauge their safety and effectiveness. As a result, we need to improve our monitoring system to ensure we catch emerging problems before they become widespread.”