CBER Transfusion Safety Mgmt Systems Regulation

On March 9, 2006 Linda Weir of FDA’s Center for Biologics Evaluation and Research gave a presentation entitled: Update on Transfusion Safety Management Systems. The slides are at the link provided.

This presentation stresses that such system require 510(k)s and are regulated as Blood Establishment Computer Systems. It also addresses wireless systems and states that conformance to IEC 60601-1-2 is requested and a declaration of conformity or test results should be included in the 510(k).

Keywords: BECS, Blood Establishment, CBER

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