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FDA biohazard bag policy

This article was originally published in The Gray Sheet

Executive Summary

FDA revokes policy of regulating biohazard plastic bags as medical devices in response to a Hershey Industries petition. Hershey Industries submitted the petition on June 9, 1993, arguing that plastic bags used to collect contaminated waste in hospitals should not be regulated ("The Gray Sheet" June 28, 1993, p. 22). FDA concurred in an Oct. 26 letter to the company, stating that the bags will not be considered devices unless they "make implied or direct medical claims related to the spread of various infectious agents such as hepatitis or AIDS"
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