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New FDA Policy On Diagnostics Studies “Fills A Big Gap,” CDRH Chief Says

This article was originally published in The Gray Sheet

Executive Summary

Companies specializing in diagnostic products should pay close attention to a new, statistics-focused guidance document from FDA, device center Director Dan Schultz says

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FDA diagnostics guidance

Agency issues guidance on statistically appropriate practices for reporting qualitative results from studies to assess diagnostic tests. The March 13 document, "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests," makes recommendations for submitting 510(k)s and PMAs for diagnostics. The guidance covers results from different types of studies and describes best practices for data collection and analysis. The guidance also outlines common inappropriate practices, focusing special attention on discrepant resolution and its associated problems. The agency received 11 comments on the 2003 draft version (1"The Gray Sheet" March 17, 2003, p. 11)...

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Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.

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