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This article was originally published in The Gray Sheet

Executive Summary

FDA expects to issue a guidance on labeling for devices containing di(2-ethylhexyl)phthalate (DEHP) "in the very near future," according to an April 5 letter from the agency to Health Care Without Harm denying the group's Oct. 5, 2001 petition for reconsideration. In September 2001, the agency denied HCWH's initial citizen petition requesting that all polyvinyl chloride medical devices be required to bear warning labels and that FDA encourage the development of alternatives to PVC (1"The Gray Sheet" Sept. 10, 2001, p. 18). In the April letter, FDA maintains that HCWH failed to satisfy the criteria required for the agency to grant a petition for reconsideration...

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