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) | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2025-P-0701

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)

Documents

Comments

1,480

Description

Open

Key Dates

Comment Period OpensMar 12, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Interim Response	Sep 9, 2025	--

Comment Statistics

Total Comments

1,480

Keywords

CDRH

Citizen Petition

The Doctor Patient Forum

Request the FDA to: Conduct a formal review to

determine whether NarxCare qualifies as a

medical device under FDA regulations. Require

that NarxCare undergo clinical validation and

transparency assessments to ensure accuracy,

Data from Regulations.gov