DEVICE WARNING LETTER VOLUME LEVELS OFF AT 544 IN FISCAL 1993; FDA REVIEWED 51.4% OF THE 87,000 MDR REPORTS RECEIVED LAST YEAR, BUDGET DOCUMENT SHOWS
This article was originally published in The Gray Sheet
Executive Summary
The number of FDA warning letters issued to device manufacturers leveled off at 544 in fiscal year 1993 (ended Sept. 30), down three from 547 the previous year.