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# Regulate NarxCare as Software as Medical Device: Petition
- URL: https://www.fdaweb.com/regulate-narxcare-as-software-as-medical-device-petition/
- Published: 2025-03-12T12:00:00.000Z
- Updated: 2026-09-14T14:55:10.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158813

The Doctor Patient Forum (DPF), which says it is a nonprofit organization advocating for chronic pain patients and healthcare providers, is petitioning FDA to classify and regulate Bamboo Health’s NarxCare platform as software as a medical device. The [petition](https://downloads.regulations.gov/FDA-2025-P-0701-0001/attachment%5F1.pdf?ref=fdaweb.com) describes NarxCare as a proprietary risk-scoring algorithm used in prescription drug management programs.

DPF specifically asks FDA to:

- conduct a formal review to determine whether NarxCare qualifies as a medical device under agency regulations;
- require that NarxCare undergo clinical validation and transparency assessments to ensure accuracy, fairness, and reliability;
- establish clear regulatory guidelines for risk-scoring software used in clinical decision-making to ensure oversight and prevent undue harm to patients; and
- mandate that companies producing such software disclose their algorithms, data sources, and methodologies for independent review.

“NarxCare and similar risk-scoring systems function as clinical decision support tools, influencing prescribing practices, access to necessary medications, and patients treatment pathways,” the petition says. “Given that Narx Care utilizes algorithmic risk calculations to influence medical decisions, it meets the definition of software as a medical device and should therefore fall under FDA regulatory authority as a medical device.”

DPF challenges Bamboo’s claim that NarxCare qualifies for exemption from FDA regulation under the 21st Century Cures Act, saying that NarxCare:

- is not merely intended to display, analyze, or print medical information;
- does not merely support clinical decision-making, but instead “interferes” with treatment outcomes;
- does not enable independent review by healthcare professionals, as required for exemption; and
- does not meet the exemption criteria that excludes software intended to support or provide recommendations to a healthcare professional about the prevention, diagnosis, or treatment of a disease or condition.