Document ID: FDA-2013-D-1358-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry: Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen Test Kits Used for Matching of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; Availability
Posted Date: 2013-11-20T05:00Z

[Federal Register Volume 78, Number 224 (Wednesday, November 20, 2013)]
[Notices]
[Pages 69693-69694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27774]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry: Recommendations for Premarket 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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
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'' 
dated November 2013. The draft guidance document provides 
recommendations to submitters and FDA reviewers in preparing and 
reviewing 510(k) submissions for nucleic acid-based HLA test kits used 
for matching of donors and recipients in transfusion and 
transplantation. The guidance provides detailed information on the 
types of studies FDA recommends for validation of HLA test kits 
submitted as 510(k)s.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 18, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in 
processing your requests. The draft guidance may also be obtained by 
mail by calling CBER at 1-800-835-4709 or 301-827-1800. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.
    Submit electronic comments on the draft 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: John Reilly, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: 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'' dated November 2013.
    The draft guidance provides recommendations to submitters and FDA 
reviewers in preparing and reviewing 510(k) submissions 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. This includes detailed 
information on the types of studies FDA recommends for validation of 
HLA test kits submitted as 510(k)s. The guidance 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.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirement of the applicable statutes 
and regulations.

II. Paperwork Reduction Act of 1995

    The draft 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

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. 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 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.

[[Page 69694]]

IV. Electronic Access

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

    Dated: November 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27774 Filed 11-19-13; 8:45 am]
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