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. Establishments must be registered and products listed within 5 days of beginning operation, and annually between October 1 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. Foreign registrants must provide the name of the United States agent, the name of each importer, and each person who imports or offers for import these blood products.
FDA published in the Federal Register of August 31, 2016 (81 FR60170) a final rule that amended FDA’s regulations governing drug establishment registration and drug listing, including establishment registration and listing for blood and blood products. Electronic submission of blood establishment and product listing information is now required under 21 CFR 607.22, unless waived in certain circumstances. Blood establishments that must register and list electronically under 21 CFR part 607 should use the electronic blood establishment registration (eBER)system to meet the requirement for electronic submission of establishment registration and product listing. FDA will stop accepting paper submissions after November 29, 2017.
Note: Beginning October 1, 2018, the CBER electronic registration and product listing system (eBER) for manufacturers of blood products and medical devices that are licensed under section 351 of the Public Health Service Act has been updated and expanded to include additional fields for establishment types, blood products, and processes. Additional changes include a requirement to provide a unique facility identifier (see 21 CFR 607.25 (a) and (b)(3)), specified by FDA as your Data Universal Numbering System (DUNS) number (issued by Dunn and Bradstreet) and replacement of Form FDA 2830 with a new form entitled Blood Establishment Registration and Product Listing for Manufacturers of Blood Products and Licensed Devices.
Forms & Instructions
- Biologic Forms
- BER Instructions for Completing the Electronic Blood Establishment Registration and Product Listing Form