Draft Guidance for Industry and Staff; Content of Investigational Device Exemption and Premarket Approval Applications for Artificial Pancreas Device Systems

This Other document was issued by the Food and Drug Administration (FDA)

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ID: FDA-2011-D-0464-0035

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Date Posted: Dec 6, 2011
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Comments Received*
Time in Range: Our major concern with the guidance document relates to the exclusion of Time in Range (TIR) as an acceptable primary endpoint. Unfortunately...
Dexcom participated in teleconferences with JDRF to develop additional comments submitted by JDRF.

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