PMA TOTAL AVERAGE REVIEW TIME TO DROP MORE THAN 33% TO ABOUT 16 MONTHS IN FY 1997, FDA DEVICE CENTER REPORT SAYS; 510(k) REVIEW TIME CUT TO 98 DAYS
This article was originally published in The Gray Sheet
Executive Summary
Average total PMA review time is expected to drop to "16 months or less" in fiscal year 1997 (ending Sept. 30), FDA's Center for Devices and Radiological Health Director says in a Sept. 8 report on device center performance.