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 ...
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 adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
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 ...
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
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MedPage Today on MSNFDA's Deadline Ignored in Nearly 30% of Device Safety ReportsNearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
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 ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
Amy S. Leopard and Eric Setterlund of Bradley discuss proposed new regulations to enhance cybersecurity protections for ...
The health ministry in June last year published revised regulations stipulating that milk with a shelf life of 30 days or ...
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