Getting started isn't dependent on any particular lab testing - the low-FODMAP diet includes elimination of lactose/fructose/sorbitol, so as you follow your plan you'll figure out if those are triggers for you.

For the things you've already done, you can tell your coach it'll be incorporated into your plan.

Thanks for sending along! Hope we can help.

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

We're building the platform so that it can support any diet, and UC/Crohn's are on our short list. (Some folks with those conditions have benefited from the Low-Fodmap diet too, although it wasn't designed for that purpose.)

thanks lauren. good luck with your company.

Glad you like the idea! Thanks for the feedback about the website. Would love to learn more - is there a particular part that especially falls short (or something that, if included, would have sold you)?

One example which is as simple as possible as complicated as necessary would be great.

Gotcha, that makes a lot of sense - appreciate it