Documento fuente o registro público

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests

FDA source document on reporting diagnostic test study results, including the choice of comparison standard and measures of test performance.

Technical guidanceU.S. Food and Drug Administration

Fuente

This document provides guidance for the submission of premarket notification (510(k)) and premarket approval (PMA) applications for diagnostic devices (tests).
fda.gov · Consultado el 2026-10-19

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated source verification

Published

2026-10-18

Updated

2026-10-20

Disclaimer

professional use

References

Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests

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