Federal Register #FDA2026N7658

FDA Classifies Prognostic Test for Chronic Kidney Disease Progression as Class II Device

This FDA final order establishes the regulatory classification for a prognostic test assessing chronic kidney disease progression: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - Renalytix AI, Inc. referenced as a device sponsor in regulatory background - Products/Services Requested: - No procurement action; this is a regulatory classification, not a solicitation - Device type: Prognostic test for assessment of chronic kidney disease progression (in vitro diagnostic measuring analytes from human samples) - No part numbers, quantities, or specific products requested - Unique/Notable Requirements: - Device classified as Class II (special controls) under 21 CFR Part 862 - Special controls include: clinical study documentation, reference interval studies, and specific labeling requirements (e.g., limiting statements about intended use) - Device is not intended for diagnosis or monitoring of treatment - No procurement, purchase, or contract action is being solicited in this notice

Description

The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression into class II (special controls). This in vitro diagnostic device measures analytes from human samples to aid in assessing the risk for progression of chronic kidney disease. The device is not intended for diagnosis, serial monitoring of disease progression, or monitoring therapeutic effects. The classification aims to ensure safety and effectiveness while reducing regulatory burdens to improve patient access to innovative devices.

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