On August 1, the FDA introduced online resources to provide information about reprocessing single-use medical devices for healthcare facilities and FAQs.
This page provides information to help healthcare facilities understand the use of reprocessed medical devices originally labeled for single-use, and to clarify the level of FDA’s regulatory oversight of these reprocessed single-use medical devices to remain as safe and effective as the original manufactured devices.
Reprocessed SUDs should be capable of withstanding necessary cleaning, disinfection or sterilization, and continue to comply with all applicable FDA requirements after each instance of reprocessing, up to the maximum number of times that the devices are intended to be reprocessed. Most reprocessed SUDs are required to present reprocessing validation testing as part of premarket submissions to the FDA.
