Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics - Guidance for Stakeholders and Food and Drug Administration Staff(Final)(使用公共人类基因变异数据库支持基于基因和基因组的体外诊断的临床有效性-利益相关者和食品和药物管理局工作人员指南（终稿）)