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HIMA reuse petition

This article was originally published in The Gray Sheet

Executive Summary

FDA denies a Health Industry Manufacturers Association request to regulate as manufacturers commercial reprocessors of disposable medical devices. The agency maintains in a July 15 response that compliance by reprocessors with good manufacturing practices "provides an appropriate measure of public health protection...by ensuring sufficient control over the individual firm's manufacturing and quality assurance operations." FDA notes the "current general absence of evidence of adverse patient outcomes attributed to the reuse of single-use devices." Instead of applying premarket requirements to reprocessors, as HIMA had requested in its September 1997 petition ("The Gray Sheet" Sept. 15, 1997, p. 6), FDA "will continue to rely on labeling and existing postmarket requirements"

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