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GUIDANCE DOCUMENT

Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation Guidance for Industry July 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-1358
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance provides recommendations to submitters (hereafter referred to as "you") and FDA reviewers in preparing and reviewing premarket notification submissions (hereafter referred to as "510(k) submission" or "510(k)") 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).

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1358.

Questions?

Contact Point
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ocod@fda.hhs.gov
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