The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
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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MedPage Today on MSNFDA's Deadline Ignored in Nearly 30% of Device Safety ReportsThe FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device ...
Medical device recall events in 2024 reached their highest level ... It’s largely because the agency is working to improve ...
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
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