CFR section
21 CFR 1271.47(a): What procedures must I establish and maintain?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.47(a) |
|---|---|
| Section | What procedures must I establish and maintain? |
| 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, Devices, Drugs, General, Other_Regulations |
| Regulation text (excerpt) | (a) General. You must establish and maintain procedures for all steps that you perform in testing, screening, determining donor eligibility, and complying with all other requirements of this subpart. Establish and maintain means define, document (in writing or electronically), and implement; then follow, review, and as needed, revise on an ongoing basis. You must design these procedures to ensure compliance with the requirements of this subpart. |
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