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FDA blood bank software policy is delaying introduction of new products, HIMA says.

This article was originally published in The Gray Sheet

Executive Summary

BLOOD BANK SOFTWARE MARKETING DELAYS are occurring because of 510(k) requirements recently imposed by FDA, Health Industry Manufacturers Association (HIMA) Technology and Regulatory Affairs Vice President Dee Simons maintained at a Sept. 3 workshop on medical device software sponsored by FDA and the National Library of Medicine. FDA's "long, arduous operation" of regulating blood bank software via premarket 510(k) procedures has resulted in the postponed release of next- generation software by manufacturers because preceding versions have not been cleared, and has decreased incentive to develop next-generation software, Simons asserted.

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