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 ...
Medical Device Network on MSN7d
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 ...
MedPage Today8d
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.
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) ...
Roll Call14d
Makary tells Senate panel he plans to review FDA job cuts
President Donald Trump’s pick to lead the Food and Drug Administration vowed Thursday to review the Trump administration’s sweeping job cuts at the agency. “I have not been involved in any ...
Business Times15d
Singapore to get new regulations to tackle online sale of non-compliant mobility devices
REGULATIONS against online marketplace platforms and retailers selling non-compliant active mobility devices will be introduced here, said Senior Parliamentary Secretary for Transport Baey Yam Keng on ...
The Australian17d
Imricor hits key milestone in FDA approval process for ablation catheter devices
Imricor is executing a modular review process with the FDA, whereby modules covering ... CE mark certification under new European Medical Device Regulation. IMR is working to improve cardiac ...
American Bar Association23d
FDA’s Final Rule on Regulation of Lab-Developed Tests: A Changing Landscape
Ted Sullivan, a partner in Quarles & Brady LLP’s Washington D.C. office, counsels and advises clients on Food and Drug Administration regulations and matters related to prescription and ...
HuffPost23d
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
with a particular emphasis on the more than 220 people in the FDA’s Center for Devices and Radiological Health. Staffers at the unit are responsible for reviewing and approving medical devices like ...
Yahoo23d
Oops! Trump Accidentally Fired FDA Medical Device Reviewers
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