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# Liver Disease Prognostic Tests Put in Class 2
- URL: https://www.fdaweb.com/liver-disease-prognostic-tests-put-in-class-2/
- Published: 2023-01-17T12:00:00.000Z
- Updated: 2026-09-14T18:12:04.000Z
- Author: David McFarland
- Tags: EIRs/483s, #legacy-id-D5153544

*Federal Register* notice: FDA is classifying prognostic tests for assessing liver-related disease progression into Class 2 (special controls). The devices are intended to measure one or more analytes obtained from human samples as an aid in assessing liver disease progression. The agency notes that they are not intended for diagnosing any disease, monitoring the effect of any therapeutic product, assessing progression to hepatocellular carcinoma, or assessing disease progression in individuals with viral hepatitis. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-01-17/pdf/2023-00480.pdf?ref=fdaweb.com).