No actual statement of the FDA, but maybe these links are useful.
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,