CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on April 12, 2018. Previous CDRH Newitems can be found on the CDRH New webpage. 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 Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) - Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases - Guidance for Stakeholders and Food and Drug Administration Staff Webinar - Final Guidances on Next Generation Sequencing-based Tests - May 24, 2018 FDA Recognition of Public Human Genetic Variant Databases Press Release: FDA finalizes guidances to accelerate the development of reliable, beneficial next generation sequencing-based tests Federal Register: Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing-Based In Vitro Diagnostics Intended to Aid in the Diagnosis of Suspected Germline Diseases Federal Register: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN170001 and DEN180001 added)