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ODE/OIVD Fiscal 2003 Annual Report In Brief

This article was originally published in The Gray Sheet

Executive Summary

Expedited PMAs review times: Average total review time for expedited PMA applications approved by the Office of Device Evaluation and the Office of In Vitro Diagnostic Device Evaluation & Safety in FY 2003 is 374.7 days, down from 471 days in FY 2002. However, the FY 2003 figure is still nearly 16 days greater than the average time for approved original PMAs. Elapsed FDA days averaged 304 for the six expedited submissions - 58 days longer than for the total PMA approval cohort mean. In November, FDA released a guidance on the expedited review program (1"The Gray Sheet" Dec. 1, 2003, p. 9)...

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