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Press Release
Pew Urges Congress to Pass Medical Device User Fee Act and Improve Marketplace Monitoring
WASHINGTON – 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 on 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."
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Pew Health Group
The Pew Health Group is the health and consumer-product safety arm of The Pew Charitable Trusts, a nonprofit organization that applies a rigorous, analytical approach to improve public policy, inform the public and stimulate civic life. www.pewtrusts.org/health.
The Pew Charitable Trusts and the Premier healthcare alliance sent the White House Office of Management and Budget a letter regarding the review of a Food and Drug Administration rule to establish a unique device identifier (UDI) system. Given the importance of this new device identification system to improve patient care and the missed statutory deadline, in this correspondence Josh Rising of Pew and Blair Childs of Premier strongly urged the Director of the Office of Management and Budget (OMB) to promptly complete review of the UDI final rule.
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A letter from Josh Rising — director of Pew's Medical Device Initiative — to The White House Office of Management and Budget, requesting a speedy review of regulations to develop a unique device identifier (UDI) system.
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'You may not yet depend on a pacemaker, defibrillator, stent, joint implant or any of the other life-changing, potentially lifesaving products made by the medical device industry. But chances are you or a family member will be a patient some day. That’s why it isn’t just the medical device industry that has a stake in the timely rollout of a long-overdue national system to better track the safety and whereabouts of devices once they’re on the market or in use."
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