If you are an establishment that recovers HCT/Ps, you must recover each HCT/P in a way that does not cause contamination or cross-contamination during recovery, or otherwise increase the risk of the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
21 CFR Part 1271 · Human Cells, Tissues, and Cellular and Tissue-Based Products
§ 1271.215 Recovery
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 1271.215
Form FDA 483 observations citing this section, fiscal years 2009–2019 (Human Tissue for Transplantation).
- Potential problems with recovery 6
Warning letters citing § 1271.215
1 FDA warning letters since 2017 cite this section :
- Utah Cord Bank LLC 11 May 2021
FDA guidance that cites § 1271.215
- Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry 6 Sept 2017
- Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry 1 Dec 2011
Amendment history
Federal Register documents that created or amended this section.
- 66 FR 5466 19 Jan 2001