Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for Industry

Issue Date: June 1, 2011
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood Products
Status: Final

Donors of Blood and Blood Components: Notification of Donor Deferral, Small Entity Compliance Guide: Guidance for Industry

The Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). According to the Small Business Administration, a “small business” within the blood industry is an enterprise with $10 million in average annual receipts. 1 This guidance is intended to help you, a small entity that collects blood or blood components for transfusion or for further manufacturing (blood or blood components), better understand and comply with the regulatory framework set forth in Title 21 Code of Federal Regulations 630.6 (21 CFR 630.6).

Download the Guidance Document