Behind The Scenes At FDA: Former CDRH Compliance Director Talks Device Recalls

摘要

Medical device manufacturers constantly worry about product recalls - and so does Tim Ulatowski. The former director of CDRH's Office of Compliance is concerned about the overall volume of devices being recalled, as well as the number of high-risk class I recalls reported by firms. "Device recalls have soared. Things appear to be out of con?trol," Ulatowski said. "It's startling to people. This kind of bad news spreads everywhere."