Olympus started selling its TJF-Q180V duodenoscope in 2010, but the FDA didn’t notice until late 2013 or early 2014 that the company had never asked for clearance to put it on the market, according to Karen Riley, deputy director of strategy for the FDA’s Office of External Affairs.
“Why didn’t we notice it? I don’t know,” Riley said.
“Can you imagine a prescription drug getting out on the market that didn’t go through the approval process?” asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who’s testified to Congress about device safety problems. “Devices need to be regulated more vigorously. This is really disturbing.” […]
Riley said she doesn’t know if the FDA will penalize Olympus for selling the device without permission.
Diana Zuckerman, a device safety expert, said they should.
“It’s like with kids. How do you teach your children to behave if there are no consequences when they misbehave?” she said.
See original article here.