Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) extended the annual medical device establishment registration period for fiscal year 2013 (FY2013) by one month. The FY2013 annual registration period that was scheduled to end on December 31, 2012, will now end on January 31, 2013. This means that an establishment may renew its registration through January 31, 2013.
The registration period is being extended to allow industry more time to comply with the new requirements of 21 CFR 807 and the Medical Device User Fee Amendments (MDUFA III) contained in the FDA Safety and Innovation Act (PL 112-144).
FDA also issued a guidance document regarding Registration under the FDA Food Safety Modernization Act (FSMA) stating that because there was a delay in FDA’s implementation of biennial registration renewal for the 2012 cycle, and registration renewal did not become available until October 22, 2012.
FDA intends to exercise enforcement discretion with respect to FSMA registration renewals submitted to FDA after December 31, 2012 for a period of 31 days, until January 31, 2013.
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