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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter L - Regulations Under Certain Other Acts Administered by the Food and Drug Administration |
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Part 1270 - Human Tissue Intended for Transplantation |
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Subpart C - Procedures and Records |
§ 1270.35 - Specific records.
Latest version.
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§ 1270.35 Specific records.
Records shall be maintained that include, but are not limited to:
(a) Documentation of results and interpretation of all required infectious disease tests;
(b) Information on the identity and relevant medical records of the donor, as required by § 1270.21(e) in English or, if in another language translated to English and accompanied by a statement of authenticity by the translator which specifically identifies the translated document;
(c) Documentation of the receipt and/or distribution of human tissue; and
(d) Documentation of the destruction or other disposition of human tissue.