The FDA has issued a Guidance for Industry document which provides recommendations to submitters and FDA reviewers on preparing and reviewing 510(k) submissions 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) (medical device).
This guidance 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. More specifically, the document addresses the types of studies and other information that FDA recommends be used in designing and conducting studies for validation of nucleic acid-based HLA test kits and preparing a 510(k) submission.
This guidance finalizes the draft guidance of the same title dated November 2013 (78 FR 69693, November 20, 2013).
Author: Patrick Ginty