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", ...
Nearly a third of FDA medical device adverse events reported late: study
Reports on medical device adverse events widely exceed FDA deadlines, according to a recent study published in the BMJ. Read ...
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 ...
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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 ...
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De-risking medical device startups with a systematic approach to innovation
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
Med Device Online3d
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 ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
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FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device ...
Medtronic slips after FDA notice on product recall (update)
Medtronic (MDT) stock turned lower as the FDA announced a most serious type of recall involving its Pipeline Vantage 027 ...
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FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
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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.