This section of the Code of Federal Regulations contains the current good manufacturing practice regulations for medical devices that have been revised and incorporated into quality system regulations for medical devices. This section is particularly relevant to blood bank computer systems. Also included are the regulations for human tissue intended for transplantation (part 1270) and Good Tissue Practices for human cells, tissues, and cellular and tissue-based products that are included in part 1271.
Hematology Transfusion Medicine