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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
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. 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

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, April 13, 2018

Subject(s):

Databases, Genetic
Reagent Kits, Diagnostic -- standards
Reproducibility of Results
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, April 1, 2019

Subject(s):

Bacillus
Equipment Safety
Reagent Kits, Diagnostic -- classification
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination

Publication:

Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, October 2019

Subject(s):

Device Approval
Drug Approval
Investigational New Drug Application
Medical Oncology
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Recommendations for clinical laboratory improvement amendments of 1988 (CLIA) waiver applications for manufacturers of in vitro diagnostic devices: guidance for industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, February 26, 2020

Subject(s):

Clinical Laboratory Techniques -- standards
Diagnostic Errors
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

6. Establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of human papillomaviruses: guidance for Industry and Food and Drug Administration staff

Publication:

Silver Spring, MD : Center for Devices and Radiological Health, September 15, 2017

Subject(s):

Device Approval
Papillomavirus Infections -- diagnosis
Reagent Kits, Diagnostic -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration