On December 5, 2012, the U.S. Food and Drug Administration (FDA) extended its annual medical device establishment registration renewal deadline from December 31, 2012 to January 31, 2013. This means that a medical device establishment may renew its registration through January 31, 2013. FDA extended the registration renewal period 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 (FDASIA).
FDASIA imposes several new Medical Device Establishment Registration and Listings requirements, effective October 1, 2012. Some of the new medical device requirements include (but are not limited to):
1) All proprietary names under which a medical device is marketed must be reported, at a minimum, when a medical device is first listed and during the annual update of registration and listing information.
2) All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the medical device into commercial distribution or return the medical device to the manufacturer or specification developer.
3) Initial importers must identify the manufacturers of the medical devices they are importing.
4) Foreign establishments that are exporting medical devices or offering medical devices for export to the U.S. must identify all known U.S. importers of their devices.
5) All establishments that are required to register must now pay the annual registration user fee as required by Food and Drug Administration Safety and Innovation Action (FDASIA).
The increase in data requirements for FDA medical device establishment registration renewal has resulted in the process taking more time than in past years. Due to this increase in time needed to complete the registration, companies should not use the extension to delay their registration but instead start it now so as to ensure timely renewal.
Further, as is the case whenever new data is required, many companies have questions regarding FDA’s new field and processes. Companies that want assistance filing their medical device registration, renewal, or listing may simply contact Registrar Corp at +1-757-224-0177. Registrar Corp’s Regulatory Specialists are available to assist companies with U.D. FDA Medical Device regulations or any other U.S. FDA requirements. For 24/7 Live Help, visit www.registrarcorp.com/livehelp