Recommendations for Premarket Notification Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation

Recommendation

7/8 May 2024

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Regulatory Requirements and Practical Implementation

In November, the FDA published a "Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Transfusion and Transplantation".

In its introduction the authority states:

"This guidance provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket 510(k) submission for human leukocyte antigen (HLA) in vitro diagnostic (IVD) device test kits. This guidance applies specifically to nucleic acid-based HLA test kits used for the matching of donors and recipients in transfusion and transplantation, whether testing is for a single locus or for multiple loci simultaneously, for which the premarket submission to FDA will be a 510(k). Although this guidance applies specifically to 510(k) submissions for HLA test kits, some of the recommendations below may also be applicable to human neutrophil antigen (HNA) and human platelet antigen (HPA) test kits. The document provides detailed information on the types of studies FDA recommends for validation of HLA test kits submitted as 510(k)s and used for the matching of donors and recipients in transfusion and transplantation."

For more information please see the complete Draft Guidance.