The annual U.S. Food and Drug Administration (FDA) medical device registration renewal deadline is today. FDA requires that owners or operators of medical device establishments for use in the U.S. register with the FDA annually. The deadline for medical device establishment registration was set to be 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.
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
Registrar Corp is a FDA regulatory compliance firm that assists companies with their Medical Device Registrations, Renewals, and other FDA requirements. For more information FDA’s Safety and Innovation Act (FDASIA) or any FDA regulation, please contact Registrar Corp 24/7 at Live Help or call us at +1-757-224-0177.