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PMA Average Review Times Flat In FY 1999; 510(k) Times Fall 10%

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health pruned average review times for 510(k) applications by roughly 10% to 74 days in fiscal year 1999 (ended Sept. 30) compared to 82 days in the previous fiscal year, according to the center's unofficial tally.

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