Subjects: Diagnostic Test Approval - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Diagnostic Test Approval ✖

1. 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

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 13, 2018
Subject(s):: 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.

2. Replacement reagent and instrument family policy for in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:: [Silver Spring, MD] : Center for Devices and Radiological Health, August 17, 2022
Subject(s):: Diagnostic Test Approval
Government Regulation
Reagent Kits, Diagnostic
United States
United States. Food and Drug Administration