Business · 12/03/2003Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for Diagnostic Tests
Summary
The Food and Drug Administration (FDA) has released a draft guidance document outlining statistical practices for reporting results from studies evaluating diagnostic tests, with the aim of improving the quality of premarket notification and premarket approval applications for these tests.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →