The Food and Drug Administration recently released finalized guidance for medical device labelers for submitting data to the Global Unique Device Identification Database. A draft version of the ...
Based on medical device cybersecurity predictions from the beginning of 2025, let's revisit what was expected to shape the ...
The FDA permits some devicemakers to file reports on device-related injuries and malfunctions in a discreet database that is not accessible to physicians or the general public, according to an ...
On July 25, 2022, the U.S. Food and Drug Administration (FDA) issued final guidance on Unique Device Identification (UDI) compliance date policies, stating that the agency will not enforce a ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
After two decades of keeping the public in the dark about millions of medical device malfunctions and injuries, the Food and Drug Administration has published the once hidden database online, ...
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s neuromuscular ...
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug ...
Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most ...
On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...
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