doodlebug

Updating with passage of time, and after reading crowd assessments

March 31 is coming fairly soon... not impossible but unlikely given how little groundwork has been laid for approval at FDA, how long approval process takes, and how FDA approval isn't needed for many health-related uses of LLMs. There is still a chance that FDA could approve a medical device built around a core non-LLM functionality that also uses an LLM in a supporting role (arguably the Innolitics example given in the question description fits this description), which probably would count as per the resolution criteria here.

FDA advisory committee meeting happening today (Thur 11/6) will shed a bit of light on regulation of LLM-based mental health chatbots at least. Transcript and more info likely to be released in the next couple days after the meeting. https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-6-2025-digital-health-advisory-committee-meeting-announcement-11062025

https://www.statnews.com/2025/11/05/fda-digital-advisers-therapy-chatbots-regulating-generative-ai/

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