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The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones.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 ...
MedPage Today on MSN1d
FDA'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 ...
Mehmet Oz, President Donald Trump’s nominee to lead Medicare and Medicaid, told senators he would focus on chronic disease ...
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
President Donald Trump’s pick to lead the Food and Drug Administration vowed Thursday to review the Trump administration’s sweeping job cuts at the agency. “I have not been involved in any ...
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