There’s a “potentially troubling gap” in the Food & Drug Administration’s oversight of medical device clinical trials, according to the Wall Street Journal — the federal watchdog agency doesn’t inspect device-making plants during trials.
The Journal, citing the failed clinical trial of an Aptus Endosystems Inc. stent graft, said the lack of oversight means “hundreds of participants in clinical-trial studies of medical devices may be at risk of receiving faulty devices.”
