In 2015 and 2016, ASHG submitted comments to the U.S. Food and Drug Administration (FDA) on two related proposed regulations for Next Generation Sequencing (NGS)-based in vitro diagnostics. Appreciative of being engaged in the process, ASHG submitted comments to further inform and clarify the issue.
Related:
- Comments on “Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)- based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases” (October 2016)
- Comments on “Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics” (October 2016)
- Comments on “Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants” (December 2015)