US FDA 2006 Testimony to Committee on Government Reform
US FDA 2006 Testimony to Committee on Government Reform
US FDA SUD Reprocessing Guidance, 2002 “Supplemental Validation Data”
Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
2000 Government Accountability Office (GAO) Report:
Single-Use Medical Devices, Little Available Evidence of Harm From Reuse, but Oversight Warranted, “…The evidence suggests that some SUDs can be safely reprocessed if appropriate cleaning, testing, and sterilization procedures are carefully followed. However, SUD