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Title (as revised 17 June 04) Part 1271 Human Cells, Tissues and Cellular TissueBased Products Subpart A General Provisions Sec. 1271.1 1271.3 1271.10 Table of Contents (Page numbers inserted in parentheses
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What is part 1271 human cells?
Part 1271 of Title 21 of the Code of Federal Regulations covers the regulations regarding human cells, tissues, and cellular and tissue-based products (HCT/Ps) as defined in section 1271.3(d).
Who is required to file part 1271 human cells?
Establishments that recover, process, store, label, package, or distribute HCT/Ps are required to comply with the regulations outlined in part 1271.
How to fill out part 1271 human cells?
Part 1271 must be filled out accurately and completely according to the instructions provided by the Food and Drug Administration (FDA) regulations.
What is the purpose of part 1271 human cells?
The purpose of part 1271 is to establish a comprehensive regulatory framework to ensure the safety and effectiveness of HCT/Ps for their intended use.
What information must be reported on part 1271 human cells?
Part 1271 requires establishments to report information related to the donor eligibility, processing, distribution, and adverse reactions associated with HCT/Ps.
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