FDA classifies a test used to track chronic kidney disease progression

The Food and Drug Administration (FDA) is classifying a specific type of medical test—one used to predict how chronic kidney disease will progress—as a Class II device.

Why it matters: This is a technical administrative action that sets the rules for how companies can market and sell these specific kidney disease tests. By moving them into the Class II category with established controls, the FDA is setting a standard path for these devices to enter the market.

Who it affects

• Medical device manufacturers who create tests for chronic kidney disease progression

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This information comes from the Food and Drug Administration via the Federal Register; readers should consult the official document before making regulatory or clinical decisions.

Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document