GlobalData on MSN1d
Nearly a third of FDA medical device adverse event reports filed late
A new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
DexCom Stock Drops as Diabetes Devices Maker Gets FDA Warning Letter
Key Takeaways DexCom received a warning letter from the Food and Drug Administration following inspections of two of its ...
JD Supra1h
FDA’s Backup LDT Enforcement Method: Specimen Collection Kits
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 ...
FDA warns of scramble for workspaces and parking spots in Monday return to office
In Thursday's meeting, the director of the FDA's Center for Drug Evaluation and Research said plans for coming layoffs were ...
STAT1d
Study reveals how often medical device makers report safety incidents late to FDA
Most medical devices in the United States come to market with limited clinical data, and device surveillance is viewed as a ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Fortune India9h
Parliament panel slams drug regulator CDSCO for delays, calls for overhaul of medical device licensing
The Committee pointed out that several medical device manufacturers are hesitant to set up units in India due to the delaying ...
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
FDA moves to rehire medical device staffers fired only days earlier
The reversal is the latest example of President Donald Trump and billionaire Elon Musk's chaotic approach to cost-cutting, which has resulted in several agencies firing, and then scrambling to rehire, ...
MedPage Today on MSN1d
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
MassDevice23h
FDA says Intuitive da Vinci 5 foot pedal recall is Class II
Class II recalls — a grade below the most serious Class I recalls — reference a situation in which the use of or exposure to ...