Cover letter

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

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
  • An exact copy of this eCopy has been permanently archived in git at tag 1.0.0 and may be retrieved from the website.

Nightscout sponsorship

To whom it may concern, Dr. Stayce Beck, et al.

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.”

The sponsor, collectively known as Nightscout contributors, may be contacted through one of the core developers:

Ben West
4521 17th St. Apt 5
San Francisco, CA 94114

Additionally, core contributors openly discuss administration of the project via an email list administered by Google groups:

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.