Regulatory Open Forum

Hello community!

We have three wireless medical devices that all have the same features and functionalities.  The radio, antennas, Wi-Fi features are also all the same.  There are some differences in main board size and some other components. 

Does anyone know if we can leverage the wireless coexistence testing performed on one of the device to apply to all three?

Can anyone point me to regulations or guidance that this would be acceptable by FDA?

Thank you in advance!

Hello Anon

FDA depends on standards for wireless coexistence. Not sure what the standards say about demonstration of similarity -- if it's explicit or left to the judgment of the test house?

https://www.fda.gov/medical-devices/digital-health-center-excellence/wireless-medical-devices