Medical Devices: Draft Guidance for Industry and FDA Reviewers; Statistical Guidance on Reporting Results From Studies Evaluating Diagnostic Tests; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA reviewers entitled "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers." This draft guidance is regarding the submission of premarket notification and premarket approval applications (PMAs) for diagnostic tests. The draft guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common practices that may not provide sufficient information to support submission. Special attention is given to describing a practice called discrepant resolution and its associated problems. This draft guidance is neither final, nor is it in effect at this time.