Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
What happened
The Food and Drug Administration (FDA) classified the prognostic test for assessment of chronic kidney disease progression into class II (special controls). This decision, effective July 24, 2026, was made because the FDA determined it provides reasonable assurance of safety and effectiveness. This action was signed by Donald Trump and will include special controls identified in the order.
Why it matters
This classification aims to enhance patients' access to beneficial innovative medical devices. By placing the device in class II, it reduces regulatory burdens, making it easier for new, similar tests to come to market.
Who it affects
- ›Patients with chronic kidney disease
- ›Medical device manufacturers
- ›Healthcare providers
- ›Food and Drug Administration (FDA)
The receipts are official. The summary is ours.
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