FDA 510(k) average review time dips to 113 days through first eight months of FY 1996.
This article was originally published in The Gray Sheet
Executive Summary
FDA 510(k) AVERAGE REVIEW TIME FALLS TO 113 DAYS through the first eight months of FY 1996, according to the agency. The review statistic, covering a period from Oct. 1, 1995 through May 31, shows a continued downward trend in 510(k) review times since the figure peaked at 184 days in FY 1994.