Blood bank software premarket submission deadline extended by one year -- FDA.
This article was originally published in The Gray Sheet
Executive Summary
BLOOD BANK SOFTWARE PREMARKET SUBMISSION DEADLINE EXTENDED by one year to March 31, 1996, FDA says in a Feb. 10 letter to manufacturers of computer software used by blood banks. FDA says it is extending the deadline from March 31, 1995 "after careful evaluation of the concerns expressed by software manufacturers, the impact of the regulatory initiative on blood establishments, and the public health significance of assuring the safety and quality of this software."