GAO report on FDA device program finds review delays based on date-of-submission cohort.
This article was originally published in The Gray Sheet
Executive Summary
GAO REPORT ON FDA MEDICAL DEVICE REVIEW PROGRAM illustrates the delays that drove reform efforts but does not address more recent improvements in premarket submission review times and backlog reductions. Using a cohort of applications based on the date of submission, the General Accounting Office report released Nov. 7 revisits dramatic increases in application review times in 1992 and 1993 and initial improvements in 1994.