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2016-07-08
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Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability
Notices
D09002ee1c2bf7b4a
D09002ee1c2bf7c5c
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases.'' As part of the White House's Precision Medicine Initiative (PMI),\1\ FDA is issuing this draft guidance to provide FDA's proposed approach on the content and possible use of standards in providing oversight for targeted and whole exome human DNA sequencing (WES) NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions. This document provides recommendations for designing, developing, and validating NGS-based tests for germline diseases, and also discusses possible use of FDA-recognized standards for regulatory oversight of these tests. These recommendations are based on FDA's understanding of the tools and processes needed to run an NGS-based test along with the design and analytical validation considerations appropriate for such tests. This draft guidance is not final nor is it in effect at this time. ---------------------------------------------------------------------------
81 FR 44614
https://www.govinfo.gov/app/details/FR-2016-07-08/2016-16201
2016-16201
fr08jy16-54
4164-01-P
Docket No. FDA-2016-D-1270
https://www.govinfo.gov/app/details/FR-2016-07-08/2016-16201
https://www.govinfo.gov/content/pkg/FR-2016-07-08/html/2016-16201.htm
https://www.govinfo.gov/content/pkg/FR-2016-07-08/pdf/2016-16201.pdf
3 p.
44614
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81 FR 44614
Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases; Draft Guidance for Stakeholders and Food and Drug Administration Staff; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-16201
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-D-1270
4164-01-P
2016-16201
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases.'' As part of the White House's Precision Medicine Initiative (PMI),\1\ FDA is issuing this draft guidance to provide FDA's proposed approach on the content and possible use of standards in providing oversight for targeted and whole exome human DNA sequencing (WES) NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions. This document provides recommendations for designing, developing, and validating NGS-based tests for germline diseases, and also discusses possible use of FDA-recognized standards for regulatory oversight of these tests. These recommendations are based on FDA's understanding of the tools and processes needed to run an NGS-based test along with the design and analytical validation considerations appropriate for such tests. This draft guidance is not final nor is it in effect at this time. ---------------------------------------------------------------------------
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 of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft
Personalized Medicine Staff, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4544, Silver Spring, MD 20993- 0002, 301-796-6206; or PMI@fda.hhs.gov; or Stephen Ripley, 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.
Guidance for Industry:
Use of Standards in the Food and Drug Administration's Regulatory Oversight of Next Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing Germline Diseases
,
CDRH-Guidance@fda.hhs.gov
PMI@fda.hhs.gov
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
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Federal Register
Vol. 81, no. 131
Office of the Federal Register, National Archives and Records Administration
2016-07-08
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https://www.govinfo.gov/app/details/FR-2016-07-08
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https://www.govinfo.gov/content/pkg/FR-2016-07-08/pdf/FR-2016-07-08.pdf
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