Nearly a third of FDA medical device adverse events reported late: study
Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
FDA classifies recall of Medtronic embolization devices as 'most serious'
The U.S. Food and Drug Administration on Tuesday classified the recall of Medtronic's embolization device as "most serious", ...
Med Device Online2d
Key QMS Considerations For Your Medical Device Startup
A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...
Medical Device Network on MSN6d
Nearly a third of FDA medical device adverse event reports filed late
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 ...
JD Supra5d
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
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 ...
Does the FDA’s future under Trump 2.0 mean innovation or instability? | Opinion
The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...
'Watershed moment': Experts call for hyperbaric chamber regulations after child's death
Industry leaders say the government failed to protect Thomas Cooper, 5, from dying in a hyperbaric chamber fire at the Oxford ...
MedTech Dive2d
FDA adds hemodialysis devices to shortage list amid B. Braun disruption
The disruption is expected to impact patient care, may require adjustments to the management of hemodialysis patients and ...
Manila Standard9d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
Yahoo Finance6d
Nearly a third of FDA medical device adverse event reports filed late
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.