Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
Fierce Biotech3d
FDA's novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...
JD Supra5d
Step by Step: FDA Cracks Down on Unauthorized Medical Device Modifications
The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...
Nearly a third of FDA medical device adverse events reported late: study
Nearly a third of medical device adverse events were not submitted to the FDA within a 30-day regulatory window, with most late reports filed more than six months after manufacturer notifications, ...
MyChesCo on MSN11h
FDA Unveils Key Updates on Rare Disease Advances, Food Safety, and Medical Innovations
The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and ...
GovInfoSecurity4d
Reading the Tea Leaves in FDA's AI-Enabled Device Guidelines
While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
STAT3d
RFK Jr. brings FDA under tighter control with HHS workforce cuts
Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.
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", ...
Med Device Online13d
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 ...
MassDevice3d
RFK Jr. plans thousands of layoffs at FDA and other HHS agencies through Musk’s DOGE team
Trump and RFK Jr. plan to cut thousands of employees from the FDA and other HHS agencies through the DOGE initiative led by ...
'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 ...