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Reuse of single-use devices

This article was originally published in The Gray Sheet

Executive Summary

FDA should not unveil its revised policy Oct. 23 at the American Society for Healthcare Central Service Professionals conference in Orlando because the meeting "has not been publicized in the original equipment manufacturer industry" and is "an obviously biased forum," the Association for Disposable Device Manufacturers tells FDA Center for Devices and Radiological Health Director David Feigal in an Oct. 12 letter. The Medical Device Manufacturers Association joins ADDM in objecting to FDA's reported plan to participate in a "closed door consensus building session" with ASHCSP Oct. 24. MDMA and other stakeholders have not been invited to participate in the private session, which is "a wholly inappropriate venue for consensus building," the association notes in an Oct. 13 letter to the CDRH director

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