Letter to Manufacturers of Blood Establishment Computer Software Products; Extension of Time Period for Premarket Submissions

Streszczenie

The Food and Drug Administration (FDA) has revised the schedule for compliance with the premarket submission requirements for manufacturers of blood establishment computer software. After careful evaluation of the concerns expressed by the manufacturers, the impact of the regulatory initiative on blood establishments, and the public health significance of assuring the safety and quality of this software, FDA concluded that a 1-year extension of the time period for premarket submissions was warranted. In this notice, the agency is publishing the text of the February 10, 1995, letter sent to the manufacturers announcing a deadline of March 31, 1996, for premarket submissions.