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1. Diagnostic tests for Alzheimer's disease: generating and evaluating evidence to inform insurance coverage policy

nlm:nlmuid-101634790-pdf

2. 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

nlm:nlmuid-101713268-pdf

3. 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

nlm:nlmuid-101734092-pdf

4. 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

nlm:nlmuid-101734132-pdf

5. Bioanalytical method validation

nlm:nlmuid-101734209-pdf

8. Technical considerations for additive manufactured medical devices: guidance for industry and Food and Drug Administration staff

nlm:nlmuid-101720001-pdf