OEM Trademarks On Reprocessed Single-Use Devices Acceptable, FDA Says

FDA regulations do not require reprocessors to remove original equipment manufacturer (OEM) trademarks and references to OEMs from reprocessed devices, but the reprocessor must make clear that it, not the OEM, is the manufacturer of the reprocessed single-use device, FDA states in its Sept. 17 denial of a petition from the Association of Disposable Device Manufacturers.