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Comment by notlob | Hacker News Reader

Can you speak a bit about how this is regulated? Are you working with the FDA Digital Health group?

The FDA is currently selectively regulating mobile apps, primarily based on risk categorization. We haven't been subject to regulation so far, but will of course work with any regulatory bodies if/when that time comes (and, of course, regulation of digital health products is continuously evolving).

I would suggest taking a more proactive approach in your relationship with the FDA, perhaps hiring an experienced consultant to either help you work with the FDA (the new "Pre-Cert" program might be worthwhile) or dial back your marketing claims to a safer position.

Right here on this Show HN you've said "Caelum is a digital therapeutic for Irritable Bowel Syndrome." This statement makes clear that you're intending for this to be used in the treatment of a specific disease (so this is a medical device and is subject to FD&C Act).

You're also said you're providing "1-on-1 digital coaching" and more specifically you "personalize each patient’s program based on their eating habits, past food trials, and demographics (age, gender, ethnicity, etc)" (so specific treatment regimens). "Minimal risk" for the FDA generally excludes individualized treatment regimens. There may be sufficient grounds to support oversight.

Thanks, will bring up these points with our advisers in this area

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