Other stuff
From Tijl:
No actual statement of the FDA, but maybe these links are useful.
https://openaps.org/frequently-asked-questions/
What does the FDA think about OpenAPS?
You can Google it, or ask them yourselves! Our take on what they’ve told us directly as well as what they’ve said publicly: their responsibility is to regulate products on the commercial market and help safeguard the public. OpenAPS is NOT a commercial product and is not sold or distributed in anyway. Individuals who build an OpenAPS are essentially doing an (n=1) experiment, which they have a right to do to/by themselves. That is not a regulated activity by the FDA.
A Patient-Designed Do-It-Yourself MobileTechnology System for DiabetesPromise and Challenges for a New Era in Medicine: http://sci-hub.tw/10.1001/jama.2016.1903
Third, there are regulatory challenges. Software that reads datafrom a medical device is technically regulated by the FDA, but onlyif it is being sold as a commercial product.3This is not the case forthe Nightscout system, which has been distributed for free via ado-it-yourself model of dissemination,
