I don't see any explicit mention or reference to SaMD and DTx products. Can either Device or Medication resources (or both) include a statement around this for future development? Otherwise, it may become its own resource to define the necessary elements better. 

See also: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd and https://dtxalliance.org/understanding-dtx/what-is-a-dtx/ 

Feel free to switch this to a Comment if deemed unnecessary as a Technical Correction.