FDA

The Food and Drug Administration of the United States government covers drug approvals and is a model for similar agencies in many nations. This section describes FDA registration, which is required of all cord blood banks that operate within the US. The FDA licensure of cord blood banks, called FDA BLA, is the next topic.

The section of US federal regulations that gives the FDA authority to regulate cord blood is Part 1271 of the Code of Federal Regulations Title 21, or 21CFR1271. Cord blood falls under the rules for "Human Cells, Tissues, and Cellular and Tissue Based-Products" (HCT/P's).

Prior to 25 May 2005, the FDA only required family cord blood banks to be registered with them, and the list of FDA registered HCT/P establishments is on-line. Since then, the FDA also conducts inspections of family cord blood banks.

The FDA rules are also designed to prevent transmission of communicable diseases. The cord blood must be tested for the following diseases:

  • Cord Blood: test for HIV-I&II, Syphilis, Hepatitis B&C, CMV, HTLV, CJD & vCJD
  • (Note that this list is almost identical to the maternal testing required by AABB and FACT)

As another safeguard against disease transmission, laboratories which process HCT/P's must follow current FDA standards of Good Tissue Practices.

In July 2012, the FDA posted their first-ever web page of cord blood information for consumers.