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 ...
MedPage Today on MSN1d
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 Healthcare14d
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 ...
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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 ...
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 ...
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) ...
Penn Live17d
FDA rehires medical device staffers fired only days earlier
Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective ...
Medical Design & Outsourcing9d
Regulatory consultant offers help for FDA’s tougher pulse oximeter draft guidance
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
Seattle Times17d
FDA moves to rehire medical device, food safety and other staffers fired days earlier
Beginning Friday night, FDA employees overseeing medical devices, food ingredients and other key areas received calls and emails notifying them that their recent terminations had been “rescinded ...
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 ...