Zdrowie i gospodarka · 03/08/2001

Draft “Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments;” Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for FDA Reviewers: Premarket Notification Submissions for Automated Testing Instruments Used in Blood Establishments" dated August 2001. The draft guidance document provides an overview of the type of information FDA reviewers should expect to be included in premarket notifications submitted to the Center for Biologics Evaluation and Research (CBER) for such devices and the approach FDA reviewers should take in reviewing premarket submissions for automated instruments used for testing in blood establishments. This document, when finalized, is intended for use by establishments that manufacture blood and blood components (e.g., in testing for blood borne pathogens, blood grouping/typing, pre-transfusion compatibility, etc.).