Source: https://www.federalregister.gov/documents/2015/08/03/2015-18956/recommendations-for-premarket-notification-510k-submissions-for-nucleic-acid-based-human-leukocyte
Timestamp: 2017-08-17 15:08:51
Document Index: 697638273

Matched Legal Cases: ['art 807', 'art 809', 'art 812', 'art 820', 'art 56', 'art 50']

Federal Register :: 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
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
FDA-2013-D-1358
Reference 18 - The Human Leukocyte Antigen System (2) re...
Reference 17 - The HLA System (Part II) (2) re Recommendations...
Reference 16 - The HLA System (Part I) (2) re Recommendations...
Reference 15 - Clinical Relevance of the HLA System in Blood...
Reference 14 - Interference Testing in Clinical Chemistry;...
Reference 13 - Evaluation of Precision Performance of...
Reference 9- IMGT Home page re Recommendations for Premarket...
List of References re Recommendations for Premarket...
https://www.federalregister.gov/d/2015-18956 https://www.federalregister.gov/d/2015-18956
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 The guidance announced in this notice finalizes the draft guidance of the same title dated November 2013.
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.
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.
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 Start Printed Page 46033heading 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.
[FR Doc. 2015-18956 Filed 7-31-15; 8:45 am]