Summary of Records [Food and Drugs] Law and Legal Definition
Pursuant to 21 CFR 1270.3 (w) [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], Summary of Records means “a condensed version of the required testing and screening records that contains the identity of the testing laboratory, the listing and interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records, and the name of the person or establishment determining the suitability of the human tissue for transplantation.”
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