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February 8th 2007: New FDA Guidance “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests”.

On March 13, 2007 FDA issued a new guidance entitled “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests”.

The document provides guidance for the submission of premarket notification (510(k)) and premarket approval (PMA) applications for diagnostic devices where the final result is qualitative (positive or negative).

The guidance describes statistically appropriate practices for reporting results from different studies evaluating in vitro diagnostic tests and comparing a new in vitro diagnostic device to another device, a recognized reference method or gold standard. The guidance is particularly useful with identifying common statistically inappropriate results reporting practices and especially, a practice called discrepant resolution.

FDA recommends to designate a reference standard and compare the new test to the designated reference standard by determining the extent of agreement between the diagnostic accuracy and sensitivity of two tests. The guidance provides additional comparison methods for such situations where a reference standard is unavailable or impractical to use.

The full text of the guidance can be reviewed at: http://www.fda.gov/cdrh/osb/guidance/1620.pdf

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

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