JD Supra6h
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 ...
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 ...
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) ...
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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 ...
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 ...
Medical Design & Outsourcing10d
Regulatory consultant offers help for FDA’s tougher pulse oximeter draft guidance
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
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.
The BMJ1d
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
Manila Standard4d
FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
Top 10 takeaways from the new HIPAA security rule NPRM
Amy S. Leopard and Eric Setterlund of Bradley discuss proposed new regulations to enhance cybersecurity protections for ...
Taipei Times4h
Revised rules would limit ‘fresh milk’ to local produce
The health ministry in June last year published revised regulations stipulating that milk with a shelf life of 30 days or ...