- FDA's approval process for de novo medical devices (the use of a novel technology wouldn't seem suited to a 510k application) is typically 12-14 months long.
- Only devices that are already in the approval pipeline have a chance of being approved before the end of March
- Two such devices seem to exist. Their applications date back to earlier than May 2022 (Wysa) and earlier than January 2025 (PathChat DX).
- Typical FDA approval rate for the novo applications is lower than 50%
Both Wysa and PathChat could reach the end of the pipeline within March, yet the former has been under review for 3 years now, implying that there might be some concerns there. Similar concerns would apply to PathChat as well, so I'm expecting both a) a longer approval and b) a lower success rate.
This would seem to be confirmed by a recent DHAC meeting (as highlighted by @grainmummy here) where the FDA signalled the intention to create an ad-hoc regulatory framework for these new devices. This would likely take months and produce as a result a new set of requirements that manufacturer would be asked to meet, further extending the timeline.
The creation of a new risk-based framework specifically for GenAI technologies is likely to take more than the 4 months that are left in this question, so the likelihood for approval of any llm-based device is very low.
I'm remaining higher than the crowd due to the existance of these two companies with products that have already been in the pipeline for enough time.
Why do you think you're right?
The recent news that Germany has summoned the Russian ambassador to formally accuse Russia of a cyber-attack on its air traffic control [1] adds layers of complexity to this question:
Just as in basically every other instance, the August 2024 cyberattack didn't cause any apparent kinetic effects, and its objective might have been purely to disrupt systems or gather intelligence.
In conclusion, once more, there is evidence that resolving this question as "Yes" might not be as easy as it seems.
[1] BBC - Germany accuses Russia of air traffic control cyber-attack
Why might you be wrong?
Anthropic reported that a Chinese state-sponsored group recently jailbroke Claude and had it execute cyberattacks on multiple global targets in an espionage campaign. [2]
Having these agentic AIs occasionally succeeded in extracting data from sensitive databases of a few of the targeted organizations, we need to update our beliefs about what LLMs can be used to achieve.
In this particular instance, it was still an expert hacker group that attempted the cyberattack, and they used AI as a tool to carry out the most labor-intensive portions of the cyberattack in a fraction of the time it would take humans. As long as there is no evidence that this will cause the number of attacks of various types to skyrocket, I remain resistant to increasing the baseline probability of a cyberattack.
Nonetheless, this is a significant development for this question.
[2] Disrupting the first reported AI-orchestrated cyber espionage campaign