Reuse of Single-Use Medical Devices, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)

“… In August 2000, FDA released a guidance document on single-use devices reprocessed by third parties or hospitals.995 In this guidance document, FDA states that hospitals or third-party reprocessors will be considered “manufacturers” and regulated in the same manner. A reused single-use device will have to comply with the same regulatory requirements of the device when it was originally manufactured.”