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Xchart and the FDA

How does the FDA view the type of service Xchart provides?

Written by Henrik Joreteg

In short, we are not a medical device, we simply display data from the medical devices. This means that the FDA does not apply its regulatory oversight to our product.
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We base this assertion on the following guidance issued by the the FDA:
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​https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices
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The functionality discussed clearly covers the type of software Xchart provides.


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