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
- Series Title(s):
- Guidance for industry
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
- Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
- Genetic Testing Germ-Line Mutation Diagnostic Test Approval Reagent Kits, Diagnostic -- standards Sequence Analysis, DNA Genomics Reproducibility of Results Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (38 pages)).
- NLM Unique ID:
- 101734092 (See catalog record)