The U.S. Food and Drug Administration (FDA) requires that owners or operators of medical device establishments for use in the U.S. register annually. The deadline for medical device establishment registration was set to be on December 31, 2012. However, on December 5, the FDA extended its annual medical device establishment registration renewal deadline (FDA Medical Device Extension) from December 31, 2012 to January 31, 2013, by enforcement discretion. As stated on the FDA website, this extended period was given 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). To register your medical device establishment with the FDA now, go to: https://www.registrarcorp.com/fda-medical-device/registration/?lang=en
FDA’s Safety and Innovation Act (FDASIA) imposes many new requirements on medical device manufacturers. Read more about the Top 10 Changes to U.S. FDA Medical Device Registrations and Listings
If you have any question about medical device establishment registration and listings requirements or any FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-244-0177.