Document published by the source itself
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
Source
This document provides guidance for the submission of premarket notification (510(k)) and premarket approval (PMA) applications for diagnostic devices (tests).
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated source verification
2026-10-18
2026-10-19
professional use
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