MobiHealthNews

FDA floats new draft guidance, created by international group, on software as a medical device

The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...
MobiHealthNews

FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps

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 The first is a draft guidance outlining categories of clinical decision ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

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 ...
MD&M East

FDA Outlines AI Medical Device Software Recommendations in Draft Guidance

On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...
https//fedtechmagazine.com

FDA Tightens Its Medical Device Cybersecurity Guidance

Nathan Eddy works as an independent filmmaker and journalist based in Berlin, specializing in architecture, business technology and healthcare IT. He is a graduate of Northwestern University’s Medill ...
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FDA seeks industry feedback on AI medical device safety monitoring

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 ...