Tick Tock, Don’t Get Blocked (Entries)!

As the smell of pumpkin spice and nutmeg abounds during this special time of year, the U.S. Food and Drug Administration (FDA) reminds food and medical device facilities that it’s time to register or renew registrations between October 1 and December 31, 2024.

This annual/bi-annual registration period is critical for facilities involved in the manufacturing, processing, packing, or holding of both animal and human food, as well as those that handle medical devices. Timely registration ensures regulatory compliance, proper oversight, and continued authorization to operate in the U.S. market.

 

A Reminder on Why Registration Is Required

Food Facility Registration      

The Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA) mandate that all domestic and foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States register with the FDA. This includes facilities handling both human and animal food products.

Food facility registration is intended to enhance food safety, improve the FDA’s ability to respond to potential contamination or emergencies, and prevent foodborne illnesses. By maintaining an updated database of food facilities, the FDA can respond more efficiently to any incidents that might pose a risk to public health.

 

Medical Device Facility Registration

Similarly, under the Federal Food, Drug, and Cosmetic Act (FDCA), establishments involved in the production and distribution of medical devices intended for use in the U.S. are required to register with the FDA. This includes manufacturers/re-manufacturers, re-packagers, re-labelers, contract manufacturers, sterilizers, specification developers, re-processors of single use devices, foreign exporters and private label distributors, and initial importers.

The device registration requirement applies to both domestic and foreign facilities. The registration process helps the FDA maintain oversight of these facilities, ensuring the safety, effectiveness, and proper labeling of medical devices distributed within the U.S. healthcare system.

 

Key Points of the 2025 Registration Renewal Process

 

Food Facility Registration (Human and Animal Food)

• All domestic and foreign facilities must register or renew their registrations between October 1 and December 31, 2024.
• Facilities that fail to register or renew by the deadline will be considered non-compliant and may face serious enforcement consequences, including being barred from distributing food within the United States.
• Facilities that are currently registered must update and/or confirm no change to their food facility registration as part of the registration renewal process.
• Each facility must designate a U.S. agent if they are located outside the United States.

Medical Device Facility Registration

• Registration is mandatory for medical device establishments that manufacture, repackage, or reprocess devices intended for distribution in the U.S.
• Companies must also submit their annual establishment registration fee. For 2025, the FDA has increased this fee to \$9,280, which applies to both domestic and foreign device establishments.
• Device listings must be updated, ensuring the FDA has current information about the devices each facility handles.

Foreign Establishments

• Foreign food and medical device facilities must have a U.S. agent, who will serve as a point of contact between the FDA and the facility.
• These facilities are subject to the same registration deadlines and compliance requirements as domestic establishments.
  
  

Consequences for Non-Compliance and/or Failure to Register or Renewed Registration

The failure to register a medical device or a food facility is a prohibited act, and may result in enforcement actions, including injunction or prosecution. FDA regulations state that the failure of an establishment to register with the FDA causes the devices or foods manufactured or processed in such an establishment to be misbranded and therefore subject to refusal of admission.  In layman terms, this means that the facilities are not able to import or distribute products within the US marketplace.

 

Steps for Facilities

To ensure compliance, facilities should ensure that all required information is up to date between now and December 31. For device facilities, facilities must submit the annual registration fee, ensuring timely processing to avoid any disruption in business operations. Medical device facilities must also confirm that their product listings are accurate and reflect the current status of each device being manufactured or distributed.

Foreign facilities must designate a U.S. agent who will handle communication with the FDA. This is a critical requirement for maintaining compliance.

After registering or renewing, we recommend keeping a copy of your company’s registration confirmation for your records and future verification.

Separately, for any facilities that may be exempt from FDA registration, we recommend re-evaluating the exemption and keeping a letter to file documenting the basis for exemption.

The FDA’s annual registration renewal period from October 1 through December 31 is essential for food and medical device facilities operating in the U.S. market. By adhering to these regulations, facilities ensure compliance, prevent costly disruptions, and contribute to the safety of the public and the integrity of the food and healthcare industries. As the deadline approaches, we strongly recommend facilities to complete their registration on time to avoid enforcement actions or interruptions in their U.S. operations.

 

 

For additional information or support in registering your facility with the FDA, or renewing an existing FDA registration, please contact us at info@garg-law.com.