A recent proposal to delay reporting of device malfunctions to FDA will weaken the already inadequate medical device reporting system at the agency, said Rita Redberg, a professor of medicine and cardiologist at the University of California San Francisco.
Redberg, editor of JAMA Internal Medicine, has been studying adverse event reporting and medical device surveillance issues for over a decade. She often opines on recommendations of U.S. Preventive Services Task Force, and in 2014, as chair of an advisory committee for the Centers for Medicare and Medicaid Services, Redberg presided over the panel that expressed low confidence in low-dose CT screening for lung cancer (The Cancer Letter, May 9, 2014).
