FDA-PUBLIC-HUMAN Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff

FDA-PUBLIC-HUMAN - 2016 DRAFT - DRAFT
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Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff


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Document Number

16008

Revision Level

2016 DRAFT

Status

Draft

Publication Date

July 8, 2016

Page Count

14 pages