FDA’s Center for Biologics Evaluation and Research issued the following for implementation Oct 1, 2006.

“Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products
Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001”

This guide has special information for inspection of military establishment and also for dealing with the American Red Cross under its consent decree. It also mention software and computer systems in many places and includes Attachment H which is specifically on Computers. This attachment indicates that any Blood Establishment Computer Systems (BECS) distributed across state lines requires a 510(k). Even if not crossing state lines and only used in an establishment for its on use is still subject to the Quality System Regulation 820.

In terms of use of a vendor supplied BECS the guide states:
“The actual use of blood bank computer software by blood establishments is subject to the CGMPs for Blood and Blood Components and the CGMPs for Finished Pharmaceuticals. Blood establishments who use vendor supplied software are required to perform user validation to ensure the software is meeting its intended use.”

The full guide is at the link provided.

Keywords: BECS, Blood Establishment, CBER