CDRHNew
Date: July 7, 2016
The following new items were added to the CDRH web pages on July 6, 2016. Previous CDRH New Items can be found on the CDRHNew Page.
- 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Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff
- Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff
- Webinar - Final Rule: Use of Symbols in Labeling - July 25, 2016
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