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GAO REPORT VERIFIES IMPROVED DEVICE REVIEW TIMES IN 1994-96; REPORT RELIES PRIMARILY ON MEDIAN-BASED APPROACH BUT ILLUSTRATES VARIATIONS IN FDA REVIEW DATA

This article was originally published in The Gray Sheet

Executive Summary

The General Accounting Office's June 3 report updating FDA's review times for medical devices illustrates the variations in FDA review data and differences in methods of calculation that can be used to justify conclusions about the device review program.

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