Hi All,
FDA has released a draft gudiance on recommendations for 510(k) submission for HLA IVD Kits.
This guidance provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions (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).
Regards,
Sreenu
FDA has released a draft gudiance on recommendations for 510(k) submission for HLA IVD Kits.
This guidance provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions (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).
Regards,
Sreenu