The FDA’s call for feedback centres on how the safety and effectiveness of AI-enabled medical devices can be maintained ...
The agency is looking for ways to detect, assess and mitigate changes to the performance of AI-enabled devices over time.
The FDA has expanded its Early Alert program to give the healthcare industry earlier visibility into potential high-risk medical device issues. The agency’s Center for Devices and Radiological Health ...
Medical Device Network on MSN
FDA scraps ‘Final Rule’ classifying LDTs as medical devices
The FDA’s move to nix its ‘Final Rule’ comes in response to the legislation’s strike down in a Texas court in March 2025.
FDA clearance is a vital milestone for ASX medical device companies, opening access to the US market while navigating the ...
Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.
The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules ...
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release. Dr.
The Food and Drug Administration's work will continue unabated even if there is a brief government shutdown. Unlike most federal agencies, the FDA is funded in large part by the industries it ...
Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...
After a successful pilot, the agency has lifted the limitations on when it will provide early information about potentially ...
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