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Eligibility Determination for Donors of Human Cells,Tissues, and Cellular and Tissue-Based Products.

Updated: Feb 19


Stay tuned to understand the intricacies, implications, and best practices that can elevate your establishment's adherence to these critical regulations.  This guidance, within the scope of Title 21 Code of Federal Regulations, part 1271, subpart C, sets forth stringent requirements for screening and testing donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Stay tuned to understand the intricacies, implications, and best practices that can elevate your establishment's adherence to these critical regulations.

This guidance, within the scope of Title 21 Code of Federal Regulations, part 1271, subpart C, sets forth stringent requirements for screening and testing donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).




Navigating the Regulatory Seas: An Overview


The FDA's guidance serves as a beacon for establishments involved in donor eligibility determinations post the effective date of 21 CFR part 1271, subpart C (since May 25, 2005). The guidance replaces its predecessor from 2007, setting the stage for enhanced precision in donor screening and testing.


Deciphering Donor Eligibility Determinations (§ 1271.50)


A. Understanding Donor-Eligibility Determination: The guidance clarifies that a responsible person, duly trained and qualified, must determine the eligibility of a cell or tissue donor. This determination hinges on comprehensive screening and testing for communicable disease agents and diseases, as outlined in 21 CFR part 1271, subpart C.


B. Relevant Communicable Disease Agents or Diseases (RCDADs): The document provides detailed insights into the two groups of RCDADs, emphasizing the importance of screening for diseases such as HIV, Hepatitis B and C, TSEs, syphilis, and more.


C. Handling Emerging Infectious Diseases: With a forward-looking approach, the FDA commits to issuing timely guidance on infectious diseases deemed relevant, ensuring establishments stay abreast of evolving risks and mitigation strategies.


Best Practices for Compliance: Establishing Procedures and Records


A. Procedure Establishment (§ 1271.47): The guidance mandates establishments to establish and maintain robust procedures for donor screening, testing, and eligibility determinations. A responsible person, equipped with adequate medical training, plays a pivotal role in overseeing these procedures.


B. Recordkeeping (§ 1271.55): Stringent record-keeping requirements outline the need for accurate, indelible, and legible records. These records must accompany each HCT/P, ensuring traceability and accountability throughout its lifecycle.


C. Quarantine Protocols (§ 1271.60): Before the completion of donor-eligibility determination, establishments must implement effective quarantine measures, distinctly identifying HCT/Ps awaiting determination. This ensures segregation from products available for release.



By comprehending the intricacies of donor eligibility determinations, establishments can forge a path toward regulatory excellence, ensuring the highest standards in the procurement and utilization of human cells, tissues, and cellular and tissue-based products. Stay tuned for more insights as we continue to decode and navigate the evolving regulatory landscape together.


Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.

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