On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...
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 ...
Medical device cybersecurity is a dynamic and evolving space. As more devices enter the market and connect to the internet, the risk of these devices being compromised increases—ultimately increasing ...
Opinion
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The FDA's hands-off approach to medical AI is a win for health-conscious consumers
Under new Food and Drug Administration (FDA) guidance on "low risk" wearable technology and software, AI-powered health tools are rapidly expanding, leading to major implications for cost, access, and ...
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released separate draft guidance on the use of the technology in the development of ...
This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
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