Relevant medical records

Relevant medical records means a collection of documents that includes a current donor medical history interview; a current report of the physical assessment of a cadaveric donor or the physical examination of a living donor; and, if available, the following:
(1) Laboratory test results (other than results of testing for relevant communicable disease agents required under this subpart);
(2) Medical records;
(3) Coroner and autopsy reports; and
(4) Records or other information received from any source pertaining to risk factors for relevant communicable disease (e.g., social behavior, clinical signs and symptoms of relevant communicable disease, and treatments related to medical conditions suggestive of risk for relevant communicable disease).

Source

21 CFR § 1271.3


Scoping language

The following definitions apply only to this part:

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