Medical Device Network on MSN1d
Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
The U.S. Food and Drug Administration said on Friday that supply interruptions of hemodialysis bloodlines, a key component in ...
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
MedPage Today on MSN2d
FDA's Deadline Ignored in Nearly 30% of Device Safety ReportsNearly 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 adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
A new study analyzing the FDA's Manufacturer and User Facility Device Experience database found that nearly one-third of medical device safety reports were not submitted within the 30-day timeframe or ...
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 U.S. Food and Drug Administration told staff this week it cannot guarantee work space or parking spots among the hurdles ...
Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to ...
Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
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