Comment from The Doctor Patient Forum
AnonymousSupportAdvocacy
Summary: The Doctor Patient Forum is submitting a supplemental comment in support of their pending Citizen Petition against NarxCare. They argue that NarxCare's overdose risk scores should be regulated as Software as a Medical Device (SaMD) because they lack transparency and do not meet the FDA's finalized Clinical Decision Support (CDS) guidance.
The Doctor Patient Forum (DPF) submits this brief supplemental comment regarding our pending Citizen Petition on NarxCare.
Since our petition was filed, FDA finalized updated Clinical Decision Support (CDS) guidance on January 29, 2026. The guidance clarifies that software must allow clinicians to independently review the basis for its recommendations and must not be relied upon primarily on opaque scores or outputs to qualify for exemption from device regulation.
NarxCare’s proprietary overdose risk scores do not meet this standard. The methodology and weighting are not transparent to clinicians, the basis for the score cannot be independently reviewed, and the scores are used in real-world practice to influence prescribing and tapering decisions.
Based on FDA’s finalized guidance, NarxCare functions as Software as a Medical Device rather than informational CDS. We respectfully ask the Agency to consider this guidance in its review of our petition.
Thank you for your time and consideration.
The Doctor Patient Forum
Contact: info@thedoctorpatientforum.com