In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm breaks down medical device fda registration renewal. Watch the video below, then read the full transcript.
Video Transcript
Hi there. I’m Lisa Capote, an FDA compliance attorney at Capote Law Firm. Today’s topic: medical device establishment registration renewal. If you manufacture, prepare, propagate, compound, or process medical devices that are distributed in the United States, you are required to register your establishment with the FDA. And registration isn’t a one-time event — it needs to be renewed annually. The FDA’s registration renewal window is October 1 through December 31 every year. Missing this window is serious. An establishment that fails to renew its registration is considered unregistered, and distributing devices from an unregistered establishment is a prohibited act under federal law. Renewal is done through the FDA’s Unified Registration and Listing System, or FURLS. During the renewal process, you’ll also need to confirm or update your device listings — making sure all the devices you manufacture are accurately listed with the FDA. Don’t let the deadline sneak up on you. Mark October 1 on your calendar and make sure your registration and listings are current and accurate. If you need help navigating the renewal process, we’re here. See you in the next video.
Have questions about FDA compliance? Contact Capote Law Firm or call (786) 207-1174 to speak with an FDA compliance attorney.