510(K) BACKLOG ALMOST ELIMINATED AT END OF FISCAL YEAR 1995, WITH ONLY NINE PENDING OVER 90 DAYS; AVERAGE TOTAL PMA REVIEW TIME DECREASES TO 357 DAYS
This article was originally published in The Gray Sheet
Executive Summary
FDA nearly has achieved its long sought after goal of eliminating the backlog of 510(k)s pending for over 90 days, with only nine remaining at the end of FY 1995 (Sept. 30).