New reprocessing business to form in Michigan
Michigan's Saginaw News reports today that a new medical device reprocessing start-up could employ 25 people in Saginaw Township by 2011. See Medical Reprocessing Business Could Hire Up to 25 Workers in Saginaw Township (02/23/2010). The formation
2008 Government Accountability Office (GAO) Report:
Reprocessing Single-Use Devices, FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents Elevated Health Risk “…After reviewing the available evidence—including FDA’s process for identifying and investigating device-related adverse events reported to
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