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 Biotech19h
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 Supra2d
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 ...
STAT13h
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.
GovInfoSecurity1d
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While recent draft guidance from the Food and Drug Administration pertaining to artificial intelligence-enable medical ...
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 ...
MassDevice16h
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 ...
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", ...
Medical Design & Outsourcing9d
De-risking medical device startups with a systematic approach to innovation
XBeta founder Frederick Kruger offers advice for medical device startups based on his firm's development of the Spiro Wave ...
ADLINK San Jose Manufacturing Center (SJMC) Achieves FDA Registration as a Contract Manufacturer, Enhancing Support for Medical Device Customers
ADLINK Technology today announced that its San Jose Manufacturing Center (SJMC), a California facility has secured ...
USA Today10d
'Watershed moment': Experts call for hyperbaric chamber regulations after child's death
The Michigan Department of Licensing and Regulatory Affairs "does not have ... the use of hyperbaric oxygen chambers as ...