SINGLE-USE DEVICE REPROCESSORS SHOULD PROVE SAFETY/EFFICACY OF PRACTICE, U.S. SURGICAL EXEC ARGUES; FDA REGULATION OF REPROCESSING INDUSTRY URGED BY HIMA
This article was originally published in The Gray Sheet
Executive Summary
Gathering of data to prove safety and effectiveness of reprocessed single-use devices is the responsibility third-party reprocessors and not FDA, U.S. Surgical VP-Quality and Regulatory Affairs Lou Mazzarese asserted Sept. 10 at the Regulatory Affairs Professional Society annual meeting in Washington, D.C.