Request that the FDA classify and regulate NarxCare, a proprietary risk-scoring algorithm used in Prescription Drug Monitoring Programs (PDMPs), as a Software as a Medical Device (SaMD)
🏛 Food and Drug Administration (FDA)FDA-2025-P-0701
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1
Total comments
1,525
all analyzed
Comment status
Open
Last activity
Jul 11, 2026
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Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document