FACT Provides Input to Donor Registry and Regulatory Agency

Posted in :: 2022 Volumne 2 :: Thursday, June 16th, 2022

Just like cellular therapy itself, donor registry and regulatory requirements evolve over time. As a voluntary, peer-based accrediting organization, FACT reviews updates to requirements that are relevant to our Standards and affect our accredited organizations. We take every opportunity to provide input on these requirements as a value-added service to the FACT community.

There have been notable requests for public comments in the first half of 2022, and FACT committees, task forces, and leadership have evaluated draft requirements and submitted comments when determined to be appropriate. These include:

  • Proposed NMDP/Be the Match Participation Criteria A00960, titled, “U.S. Apheresis and Collection Center Participation Criteria”: FACT expressed support for NMDP/Be the Match’s efforts to simplify and streamline criteria, requested clarification regarding whether the proposed criteria reflect a change in current practice regarding Apheresis Centers’ option to decline the opportunity to share NMDP collection center adult results with other NMDP clients, and reiterated support of retaining this option for NMDP collection centers.
  • Draft Version of 25th Edition NMDP Standards: FACT expressed support for the National Marrow Donor Program (NMDP)/Be the Match’s efforts to streamline and simplify its Standards and provided recommendations for increasing clarity regarding the requirements and the scope of related accrediting organizations (e.g., FACT, the Joint Accreditation Committee of ISCT & EBMT (JACIE), and WMDA/).
  • Draft guidance from the FDA proposed rule titled, “Medical Devices; Immunology and Microbiology Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests”: FACT expressed its support of the comments submitted under separate cover by the American Society for Histocompatibility & Immunogenetics (ASHI) and opposed FDA’s proposal to classify HLA devices into class II with special controls.
    Read the proposed FDA rule
  • Draft guidance from the Food and Drug Administration (FDA), titled: “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products”: FACT comments focused on the importance of relationships between cellular therapy product manufacturing companies and the health care institutions in their collection and treatment site networks to enhance patient safety, product efficacy, and patient access while minimizing the burdens on the health care institutions. FACT also recommended references to ISBT 128 coding and labeling and ASTCT consensus criteria for grading cytokine release syndrome and neurologic toxicities.
    Read the draft FDA guidance