Skip to main content
Xchart and the FDA

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

Henrik Joreteg avatar
Written by Henrik Joreteg
Updated over a week ago

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.

We base this assertion on the following guidance issued by the the FDA:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices

The functionality discussed clearly covers the type of software Xchart provides.


Did this answer your question?