Code of Federal Regulations

Beschreibung

This section of the Code of Federal Regulations codifies the general and permanent rules of the FDA. Section 7, Enforcement Policy, contains the requirements for Recall. Section 11 contains requirements for electronic records and electronic signatures that will be important to any blood bank utilizing computerized records. Section 21 covers protection of privacy, Section 50, the protection of human subjects and Section 56 covers Institutional Review Boards.

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Hematology Transfusion Medicine

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