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 ...
JD Supra4h
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 ...
MedPage Today on MSN2d
FDA's Deadline Ignored in Nearly 30% of Device Safety Reports
The FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device ...
Modern Healthcare15d
Medical device recalls hit a four-year high in 2024. Here’s why
Medical device recall events in 2024 reached their highest level ... It’s largely because the agency is working to improve ...
JD Supra3d
Prescription Medical Device Manufacturers, Distributors, and the NABP: The Role in State Licensing
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
MedTech Dive4d
New FDA pulse oximetry guidelines could stall under Trump
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 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) ...
Makary tells Senate panel he plans to review FDA job cuts
FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...
Modern Healthcare8d
FDA labels Philips' recall of Tack Endovascular Systems a Class I
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...
EurekAlert!2d
Over 1.2 million medical device side-effect reports not submitted within legal timeframe
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 ...