Medical Device Manufacturers Registration Renewal Deadline Pushed to January 31, 2013
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
The Food and Drug Administration Safety and Innovation Act (FDASIA), passed in July 2012, is intended to help increase … READ MORE


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