FDA RELEASES GUIDANCE ON REPORTING RESULTS OF DIAGNOSTIC TEST STUDIES

The FDA issued draft guidance on reporting results from studies evaluating diagnostic tests. The guidance also identifies common inappropriate practices, the agency said.

The document, "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers," provides recommendations for the submission of 510(k) and premarket approval applications for diagnostic tests.

The guidance covers results from different types of studies evaluating diagnostic devices and gives recommendations on data collection, analysis and resolution of discrepant results.

The agency said special attention is given to a practice called discrepant resolution and its associated problems.