Medical Device Network on MSN12h
Nearly a third of FDA medical device adverse event reports filed lateA new study found that 9.1% of medical device AEs were reported to the FDA 180 days later than required over a three-year ...
MedPage Today on MSN1d
FDA's Deadline Ignored in Nearly 30% of Device Safety ReportsThe FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device ...
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.
MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...
Panel raises concern over regulatory roadblocks affecting medical devices sector: Gireesh Babu, New Delhi Thursday, March 13, 2025, 08:00 Hrs [IST] The delays and lack of transpar ...
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
If confirmed, Makary would run one of the nation's leading health agencies, overseeing the regulation of food and drugs.
The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...
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 ...
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