On January 6, 2026, the U.S. Food & Drug Administration (FDA) updated two guidance documents, General Wellness: Policy for Low Risk Devices ...
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FDA announces regulatory exemptions for 'non-medical grade' devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less regulatory oversight.
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical ...
A recently released analysis report from the Deloitte Center for Government Insights that examines the US’s current and proposed software as a medical device (SaMD) regulatory landscape, and includes ...
This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...
A recent report said medical device software is under-regulated and recommended the Food and Drug Administration develop procedures to ensure the safety and efficacy of products before they go to ...
Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...
The US Food and Drug Administration (FDA) is seeking industry comment on practical approaches towards measuring and evaluating the performance of AI-enabled medical devices in the real world. With a ...
The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...
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