21 C.F.R. § 1270.35 Specific records.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 1270—HUMAN TISSUE INTENDED FOR TRANSPLANTATION
Subpart C—Procedures and Records
§ 1270.35 Specific records.
