Medical Device Manufacturers Registration Renewal Deadline Pushed to January 31, 2013
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December 21, 2012
Law & Regulatory, Medical Devices
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Tags: 2012, 2013, deadline, devices, establishment, FDA, FDASIA, fees, grey market, III, MDUFA, medical device, registration, Renewal
The U.S. Food and Drug Administration (FDA) has extended the registration renewal deadline for medical device establishments from Dec. 31, 2012 to Jan. 31, 2013. In addition, FDA has been drastically overloaded and delayed in responding to communications from the extra MDUFA III requirements this year and is asking industry to allow two weeks for responses. FDA is also rolling out a new online registration and listing platform.
Background
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