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Single-use device reprocessing FDA draft policy expected this summer.

This article was originally published in The Gray Sheet

Executive Summary

SINGLE-USE DEVICE REPROCESSING POLICY DEVELOPMENT BY FDA is being undertaken by a recently formed committee in the agency's Center for Devices and Radiological Health. Headed by Larry Spears, acting director in the Division of Enforcement III in CDRH's Office of Compliance, the committee expects to have a preliminary policy statement ready for presentation to the FDA commissioner's office by early summer.



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