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U.S. Department of Health and Human Services

Medical Devices

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FDA Safety and Innovation Act

The FDA Safety and Innovation Act (FDASIA) includes the Medical Device User Fee Amendments of 2012 (MDUFA III) as well as other medical device provisions. MDUFA III will be in effect for five years beginning October 1, 2012. It includes performance goals and user fees paid to the Food and Drug Administration (FDA) by medical device companies when they register and list with the FDA and when they submit an application to market a medical device in the U.S. Other provisions of FDASIA begin immediately. These will change the way the FDA approves clinical trials, provide a new de novo pathway for risk-based classification of devices, expand FDA's postmarket surveillance capabilities, shorten timelines for scheduling appeals meeting and issuing decisions, and change the process for reclassification of devices.