Medtech industry groups said the FDA should use existing regulatory and quality tools to monitor performance, while medical ...
December 1, 2025Sara Brenner, M.D., MPHPrincipal Deputy CommissionerU.S. Food and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993Submitted ElectronicallyRE: FDA-2025-N-4203 Request ...
The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...
The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...
The AHA provided recommendations to the Food and Drug Administration today in response to a request for information on the measurement and evaluation of artificial intelligence-enabled medical devices ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The AHA is calling for a framework that balances innovation with appropriate safeguards to protect privacy and patient safety.
The pharmaceutical and medical device industries stand at an inflection point. After decades of reliance on traditional ...
CDSCO releases MedTech Mitra's handbook for innovators in IVD medical devices segment: Our Bureau, New Delhi Wednesday, December 10, 2025, 08:00 Hrs [IST] The Central Drugs Standa ...
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