The US Food and Drug Administration (FDA) announced it has initiated a process aimed at improving patient safety through better postmarketing oversight of medical devices—an action that comes in the midst of some high-profile reports of recall notices, subpoenas, and corporate warning letters about problematic cardiac devices.
At a January 20 press conference, the FDA's Center for Devices and Radiological Health launched an initiative to improve safety monitoring of medical devices after they reach the market, by creating a regulatory environment that enables investigators to move more quickly to identify, analyze, and act when medical device problems surface. Daniel Schultz, MD, the center's director, said the announcement came after about one year's work.
Mitka M. Medical Device Oversight Under Scrutiny. JAMA. 2006;295(10):1109-1110. doi:10.1001/jama.295.10.1109