All owners or operators of establishments that manufacture blood products are required to register with the FDA, 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.
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.
Form FDA-2830, Blood Establishment Registration and Product Listing, is used for submission of registration and product listing information to the FDA. The form (and accompanying instructions) may be downloaded to complete and submit by mail. Alternatively, the information may be submitted electronically. Instructions for completing the electronic form are available below.