Comment from Jeanette French
AnonymousSupportIndividual
Summary: The commenter is requesting that the FDA classify NarxCare as Software as a Medical Device (SaMD) to ensure it is regulated and transparent. They argue that the current lack of oversight affects real medical care and that patients and doctors lack visibility into how the scores are generated.
Please classify NarxCare as Software as a Medical Device so it can be regulated and transparent. Asking FDA to regulate NarxCare as a medical device. This score can follow patients into exam rooms, pharmacies, and emergency departments, affecting real medical care. Nobody ever approved NarxCare. Nobody regulates it. Patients usually do not get to see the score. Doctors using it do not know what goes into it.