FDA Blood Establishment Registration

FDA Blood Establishment Registration

FDA blood establishment registration and product listed may be one of the more overlooked registrations completed by our firm. The focus is often on food, cosmetic, device or drug. Biological products regulated by the Center for Biological Research and Evaluation (CBER) are also subject to regulation. CBER regulates a range of products including vaccines, blood, and other biologics.

All owners or operators of establishments that manufacture blood products are required to complete a FDA blood establishment registration, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65. A list of every blood product manufactured, prepared, or processed for commercial distribution must also be submitted. Products must be registered and listed within 5 days of beginning operation, and annually between November 15 and December 31. Blood product listings must be updated every June and December.

The exemption for FDA blood establishment registration is narrow and should be carefully reviewed. It applies to only a small group of five types of activities that fall outside the registration requirement. Whenever claiming an exemption from registration is important to document the rationale and root it to the relevant CFR.

Blood establishments located outside of the United States that import or offer for import blood products into the U.S. are required to register with FDA. The name of the United States agent, the name of each importer, and each person who imports or offers for import these blood products must also be provided.

The registration process can still be completed using a paper form, but we recommend using the electronic submission process for a quicker-turnaround time. Click here to find a list of FDA registered blood establishments.

We can walk you through the FDA blood establishment and product listing process, exemptions, and also act as your US Agent.

Contact our Washington D.C. or Charlotte office to learn more.