Open-But-Unused SUD Reprocessing Will Not Be Pursued - FDA's Kessler
This article was originally published in The Gray Sheet
Executive Summary
FDA expects to issue a final guidance by August on its approach to regulate reprocessing of single-use devices (SUDs) by third-party facilities, according to Larry Kessler, director of the Center for Devices and Radiological Health's Office of Surveillance and Biometrics.