Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER L - REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
/ PART 1270 - HUMAN TISSUE INTENDED FOR TRANSPLANTATION
/ Subpart C - Procedures and Records / § 1270.35 Specific records.
§ 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.