The FDA requires firms that manufacture foods, pharmaceuticals and medical devices to register their facilities on an annual or biennial basis, depending on the product category. Keep in mind, FDA assesses a Medical Device establishment registration user fee annually. Drug products and medical device products must also be listed with the FDA.
Any changes or updates to a facility’s information, such as address, contact information, or designated U.S. Agent, should the location be based outside of the U.S., must be reported in a timely manner. Changes to a drug listing must also be updated as soon as possible. The agency dictates these changes be reported, at the very least, the June or December following such a change.
FDA uses facility registration and product listing information as part of their compliance reviews for cross referencing product listings and forms at U.S. ports of entry. Discrepancies can cause products to be considered misbranded and / or potentially lead to the detaining of goods. Additionally, FDA may at any time make announced or unannounced inspections at registered facilities, so it is imperative that all information uploaded into the FDA system is done with care and accuracy.
EAS offers registration and listing services to our clients, as well as appointment as the U.S. Agent for foreign clients. Our comprehensive services enable your firm to outsource these important, yet cumbersome, administrative tasks to our experts. EAS helps you to keep track of compliance deadlines, applicable user fees and acts as a conduit of information between your firm and the FDA.
For more information, we invite you to view our website and Video Shorts which offer quick snapshots of many of EAS’s services. For more information on our registration and listing services specifically, you may wish to view the “Registrations and Listing Services” video found in the third row. For a more detailed look at many FDA compliance requirements we invite you to view our On-Demand regulatory webinars which offer regulatory information on a variety of topics. More information on U.S. Agent requirements can be found here.
Contact EAS with any questions on registration and listings or to engage EAS as your U.S. Agent. The process is simple, and the benefits can be endless.