CFR section
21 CFR 1271.55(b)(1): 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(b)(1) |
|---|---|
| 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 | Devices, Other_Regulations |
| Regulation text (excerpt) | (1) A statement that the communicable disease testing was performed by a laboratory: (i) Certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493; or (ii) That has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services in accordance with those provisions; |
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