FDA regulations (21 CFR 607) require establishments that engage in the manufacture of blood products to register and list their products with the agency. If you are a manufacturer that is required to register, you must do so within 5 days after beginning operations. Registrations must be updated annually between November 15 and December 31, and blood product listings must be updated every June and December.
Form FDA-2830, Blood Establishment Registration and Product Listing, is used for submission of registration and product listing information to the FDA. The information may be submitted electronically (eBER). Instructions for completing the electronic form are available on the web.
Form FDA-2830 (and accompanying instructions) may also be downloaded to complete and submit by mail. The Blood Establishment Registration and Listing page provides access to the Biologic Forms page (Form FDA-2830), BER instructions for completing the electronic form, and other information.