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FDA MDUFA Legislative Pact Omits Key Reforms in GOP Draft

March 28, 2012
Unlike a draft bill on device user fee reauthorization circulating in the House, draft legislative language published by the FDA does not incorporate GOP proposals to streamline the regulatory process and encourage business development. But that language could be incorporated into the measure. The FDA published its Medical Device User Fee Act (MDUFA) commitment letter and draft legislative language, setting premarket application fees at $248,000 for fiscal 2013.
Devices & Diagnostics Letter