« Previous
Next »
Titles
- Administrative procedures for CLIA categorization: guidance for industry and Food and Drug Administration staff1
- Bioanalytical method validation1
- Class II special controls guideline: in vitro diagnostic devices for Bacillus spp. detection : guideline for industry and Food and Drug Administration staff1
- 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 staff1
- Deciding when to submit a 510(k) for a change to an existing device: guidance for Industry and Food and Drug Administration staff1
- 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 staff1
- Investigational in vitro diagnostics in oncology trials: streamlined submission process for study risk determination1
- 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 staff1
- 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 staff1