Food and medical device facilities need to renew registration with the FDA by December 31.

If you are operating either a U.S. or foreign facility with food or medical equipment, now is the time to renew registration with the FDA. Failure to register will lead to expiration and subsequent roadblocks. So, registering now can save you considerable time and hassle later.

Food Facility Registration

Food facility operators, domestic or international, must renew FDA registration every even-number year in compliance with the Food Safety Modernization Act. If your facility handles food product processing, production, or storage, you will need to submit new registration by the deadline.  If you are an Importer, please check with your foreign supplier to confirm they have renewed their registration.

Importantly, the FDA requires a Unique Facility Identifier (UFI) with each registration application. The administration has released new guidance on compliance with the UFI requirement.

Visit the FDA website for more information about registering your food facility.

Medical Device Facility Registration

The FDA requires annual registration for facilities that handle medical devices. Whether your operation produces and distributes medical devices in the U.S. or imports foreign devices for commercial use, it is crucial to complete yearly registration by the December 31 deadline. If you are unsure about the registration requirements for your medical device facility, the FDA itself has provided a list of criteria that require an establishment to register.

Consult the Experts for Compliance Guidance

Scarbrough Consulting is ready to jump in and help you navigate challenges like registering your facility with the FDA. We are happy to answer questions and help you make qualified, confident decisions. You can work directly with industry experts who understand the ins and outs of legal compliance around global supply chains. Chat with a Scarbrough team member today to learn how to optimize your logistics operation.