Thanks Scott Strumello for the email tip that the FDA has issued Guideline for Artificial Pancreas. I will be giving them a good reading and if you are so inclined here are some links:
Reuters: FDA: Diabetes device plan may help patients faster
FDA: Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems
FDA: Press Release
Reuters: FDA: Diabetes device plan may help patients faster
FDA: Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems
FDA: Press Release
give us the cliff notes when you are done.
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