Still a young process the Regulation for AI in US and UK. Not considering likely at this moment
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New Prediction
New Prediction
Probability
Answer
20%
Yes
80%
No
Why do you think you're right?
Files
Why might you be wrong?
A rapid change in regulation and bussiness models
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New Prediction
Probability
Answer
0%
Yes
100%
No
Why do you think you're right?
Reading about the question and checking info in the web, i can conclude this is a question with a No Likelihood
Files
Why might you be wrong?
My sources could be wrong
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Why do you think you're right?
Without proper testing and all the new information about how AI hallucinates, it is not likely in this moment
Why might you be wrong?
A quick improvement in the models could lead to a fast implementation of the models and then the approval of the device
Fellow forecaster, I was reading your input and noticed this while researching:
'"As of November 2025, several medical software products using large language models (LLMs) are already being reviewed by the FDA, with some applications submitted in 2024 and early 2025.The FDA has released clear guidelines during 2024–2025 on how to manage AI and machine learning-based medical software, including rules for LLMs, plans for handling updates, and transparency. The overall approval process is mostly set.
At least two medical devices classified as Class II, which use LLMs to help with clinical decisions like creating radiology reports and chatbot triage, have finished their detailed reviews or are close to final approval.
One well-known example is a large radiology co-pilot software that completed important tests in mid-2025 and is expected to get FDA approval by early 2026 or sooner."
Sources
Artificial Intelligence in Software as a Medical Device: Outlines coordinated FDA approach across centers; updated Dec 2024 with final PCCP guidance for AI/ML changes, including generative AI.
Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: FDA's dynamic list of cleared devices (1,250+ as of July 2025); commits to tagging LLM-based devices for transparency.
Marketing Submission Recommendations for a Predetermined Change Control Plan: Final Dec 2024 guidance on handling iterative AI updates, enabling faster post-clearance modifications—key for LLM scalability.
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Jan 2025 draft; addresses generative AI risks/benefits, performance monitoring, and submissions for AI-DSFs like LLMs.
AI/ML-Based Software as a Medical Device (SaMD) Action Plan: Foundational 2021 plan, updated through 2025 with emphasis on real-world evidence for adaptive models.
I hope you find this info usefull
Best regards.