Relevant Medical Records [Food and Drugs] Law and Legal Definition
Pursuant to 21 CFR 1270.3 (t) [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter L Regulations under Certain Other Acts Administered by the Food and Drug Administration; Part 1270 Human Tissue Intended for Transplantation; Subpart A General Provisions], Relevant Medical Records means a collection of documents including a donor medical history interview, a physical assessment of the donor, laboratory test results, medical records, existing coroner and autopsy reports, or information obtained from any source or records which may pertain to donor suitability regarding high risk behaviors, clinical signs and symptoms for HIV and hepatitis, and treatments related to medical conditions suggestive of such risk.
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