80 FR 46032 - Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``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.'' The guidance document provides recommendations to submitters and FDA reviewers in preparing and reviewing premarket notification submissions (hereafter referred to as ``510(k) submission'' or ``510(k)'') for HLA in vitro diagnostic (IVD) device test kits. The 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). The guidance announced in this notice finalizes the draft guidance of the same title dated November 2013.

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46032-46033]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1358]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a document entitled ``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.'' 
The guidance document provides recommendations to submitters and FDA 
reviewers in preparing and reviewing premarket notification submissions 
(hereafter referred to as ``510(k) submission'' or ``510(k)'') for HLA 
in vitro diagnostic (IVD) device test kits. The 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). The guidance 
announced in this notice finalizes the draft guidance of the same title 
dated November 2013.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in 
processing your requests. The guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Valerie A. Butler, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a document entitled 
``Recommendations for Premarket Notification (510(k)) Submissions for 
Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching 
of Donors and Recipients in Transfusion and Transplantation; Guidance 
for Industry.'' The guidance provides recommendations to submitters and 
FDA reviewers in preparing and reviewing 510(k) submissions for IVD 
device test kits, specifically for 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. The guidance includes detailed information on the 
types of studies FDA recommends for validation of HLA test kits 
submitted as 510(k)s. More specifically, the guidance document 
addresses the types of studies and other information that FDA 
recommends to be used in designing and conducting studies for 
validation of nucleic acid-based HLA test kits and preparing a 510(k) 
submission.
    In the Federal Register of November 20, 2013 (78 FR 69693), FDA 
announced the availability of the draft guidance of the same title 
dated November 2013. FDA received several comments on the draft 
guidance and those comments were considered as the guidance was 
finalized. In addition, editorial changes were made for purposes of 
clarity and accuracy. The guidance announced in this notice finalizes 
the draft guidance dated November 2013.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on premarket notification (510(k)) submissions 
for nucleic acid-based HLA test kits used for matching of donors and 
recipients in transfusion and transplantation. It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 809 have been approved under OMB control 
number 0910-0485; the collections of information in 21 CFR part 812 
have been approved under OMB control numbers 0910-0078 and 0910-0582; 
the collections of information in 21 CFR part 820 have been approved 
under OMB control number 0910-0073; the collections of information in 
21 CFR part 56 have been approved under OMB control number 0910-0130; 
and the collections of information in 21 CFR part 50 have been approved 
under OMB control number 0910-0586.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the

[[Page 46033]]

heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, 
and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18956 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P