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.
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.