CFR section
21 CFR 1271.55(d)(2): What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.55(d)(2) |
|---|---|
| Section | What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain? |
| Part | PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS |
| Subpart | Subpart C-Donor Eligibility |
| Subchapter | 21 CFR L Other |
| Product types cited | Biologics, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (2) All records must be accurate, indelible, and legible. Information on the identity and relevant medical records of the donor, as defined in § 1271.3(s), must be in English or, if in another language, must be retained and translated to English and accompanied by a statement of authenticity by the translator that specifically identifies the translated document. |
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