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House Democrats renew call for medical device probes amid debate on user fees

By Julian Pecquet - 01/20/12 12:27 PM ET

Democrats on the Energy and Commerce Committee on Friday renewed their call for a congressional probe into two healthcare products amid partisan squabbling over the federal approval process for medical devices.

The panel Democrats first requested hearings on the "Lap-Band" weight loss device and urogynecologic surgical mesh in October. They say the two products have developed "serious defects" after being implanted in patients.

The larger goal of the hearings, however, is to shed light on concerns Democrats and patient advocates have with the safety of the federal approval process for medical devices. 

As Congress prepares to reauthorize user fees that device makers pay for Food and Drug Administration regulators to review their products, Republicans and the device industry are pushing hard for a more streamlined and quicker process.

"We remain concerned that the Committee's previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation," the Democrats wrote in a letter to top Republicans on the panel. "We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act."


Source:
http://thehill.com/blogs/healthwatch/medical-devices-and-prescription-drug-policy-/205373-house-democrats-renew-calls-for-medical-device-probes-amid-debate-on-user-fees

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