Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...

The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...

Industry leaders say the government failed to protect Thomas Cooper, 5, from dying in a hyperbaric chamber fire at the Oxford ...

THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...

The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and ...

Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...

If confirmed, Makary would run one of the nation's leading health agencies, overseeing the regulation of food and drugs.

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration ... concerns or pursue other regulatory actions.