How does FDA regulate cord blood that is banked?
FDA has in place a risk based approach for the regulation of human cells, tissues and cellular and tissue-based products (referred to as HCT/Ps for short). HCT/Ps include cord blood, and are subject to FDA requirements regarding manufacturing steps, including the recovery, processing, storage, labeling, packaging or distribution of the products, as well as the screening and testing of the donor (also known as donor eligibility). These regulations apply to cord blood that is stored at public or private banks. Banks that provide cord blood products for use in an unrelated individual (public use) must follow these and additional FDA requirements. Establishments that perform any of these manufacturing steps must register with FDA and list their products and each of the manufacturing steps they perform. Registration with FDA doesn’t mean a firm is “endorsed” by the agency, it simply means the firm has notified FDA that it is performing one or more manufacturing steps.
