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    Are there laws that prohibit providing this tool in a non-FDA approved manner so long as the tool is clear that that is the case?

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      From what I understand, the answer currently is No. The artificial pancreas movement is gaining a lot of steam and this was a worry early on. It was interpreted that there are no laws preventing use of devices in this manner, but no one can sell a pre-packaged product that unifies monitoring and insulin pumping without FDA approval.