FDA 510(k) AVERAGE REVIEW TIME DROPS TO 114 DAYS FOR FIRST HALF OF FISCAL 1996; ODE'S ALPERT BELIEVES 510(k) "SUPPLEMENTS" FOR DEVICE CHANGES WORTH EXPLORING
This article was originally published in The Gray Sheet
Executive Summary
FDA's 510(k) review performance to date in fiscal year 1996 (ending Sept. 30) puts the agency on track to best its review time projections for the year, as well as FY 1997 projections based on the receipt of $24.5 mil. in user fees.