21 CFR 1271.47: What procedures must I establish and maintain?
Requires establishments to define, document, implement, and maintain responsible-person-approved procedures for donor eligibility, screening, and testing steps, keep them available where work occurs, and record, justify, and approve departures before distribution.
Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products · Subpart C, Donor Eligibility
Cited over time
483s citing 1271.47, by yearMost citations in 2025. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2025.
Recent 483s citing 1271.47
- Donor Alliance, Inc. · Denver, ColoradoProcedures were not designed to ensure compliance with the donor eligibility… Jan 15, 2026
- Americord Registry LLC · Somerset, New JerseyEMPLOYEE(S> SIGNATURE You did not establish and maintain procedures for testing,… Nov 17, 2025
- Alabama Center for Reproductive Medicine · Birmingham, AlabamaYou did not establish and maintain procedures for screening and determining the… Sep 15, 2025
- Center for Assisted Reproduction (CARE · Bedford, TexasYou did not establish and maintain procedures that address the accompanying records… Sep 10, 2025
- Boston IVF Fertility Services at The · Newburgh, IndianaYou did not establish and maintain procedures for screening of HCT/P donors… Sep 9, 2025
The regulation text
§ 1271.47 What procedures must I establish and maintain?.
(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.
(b)Review and approval. Before implementation, a responsible person must review and approve all procedures.
(c)Availability. Procedures must be readily available to the personnel in the area where the operations to which they relate are performed, or in a nearby area if such availability is impractical.
(d)Departures from procedures. You must record and justify any departure from a procedure relevant to preventing risks of communicable disease transmission at the time of its occurrence. You must not make available for distribution any HCT/P from a donor whose eligibility is determined under such a departure unless a responsible person has determined that the departure does not increase the risks of communicable disease transmission through the use of the HCT/P.
(e)Standard procedures. You may adopt current standard procedures, such as those in a technical manual prepared by another organization, provided that you have verified that the procedures are consistent with and at least as stringent as the requirements of this part and appropriate for your operations.
Questions
What does 21 CFR 1271.47 require?
Requires establishments to define, document, implement, and maintain responsible-person-approved procedures for donor eligibility, screening, and testing steps, keep them available where work occurs, and record, justify, and approve departures before distribution.
Which sections are cited alongside 1271.47?
In the same 483s, investigators most often also cite 1271.50 (How do I determine whether a donor is eligible?), 1271.55 (What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?), 1271.75 (How do I screen a donor?), 1271.80 (What are the general requirements for donor testing?).