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Cover letter | ||
============ | ||
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E-Copy Statement | ||
---------------- | ||
To the | ||
| Food and Drug Administration | ||
| Center for Devices and Radiological Health | ||
| Document Control Center - WO66-G609 | ||
| 10903 New Hampshire Avenue | ||
| Silver Spring, MD 20993-0002 | ||
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The eCopy is an exact duplicate of the paper copy, except for the | ||
following differences: | ||
* for security, a wet, inked signature is only provided on the hard | ||
copy, and absent in the digital and online versions of this ecopy | ||
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Nightscout sponsorship | ||
---------------------- | ||
To whom it may concern, Dr. Stayce Beck, et al. | ||
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This presubmission is to discuss open source projects and FDA | ||
This premarket submission is to discuss open source projects and FDA | ||
oversight. Specifically, this is to discuss the Nightscout project, | ||
aka "CGM in the Cloud." | ||
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@@ -24,3 +40,8 @@ project via an email list administered by Google groups: | |
* https://groups.google.com/forum/?utm_medium=email&utm_source=footer#!forum/nightscout-core-dev | ||
* [email protected] | ||
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We request a meeting to discuss the risks and safety Nightscout. | ||
Please review the following discussion of the device description, | ||
future plans, and questions. | ||
We are happy to schedule meetings as needed. | ||
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