Kidney Disease Test Gets Easier FDA Approval Path
Published Date: 7/24/2026
Rule
Summary
The FDA is officially putting a special kidney disease test into Class II, meaning it’s safe and effective but with some extra rules to keep it that way. This change helps patients get access to this cool new test faster by cutting down red tape. The new classification is effective July 24, 2026, and could save companies time and money while making sure the test works well.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Class II Decision Expands Patient Access
The FDA placed the prognostic test for chronic kidney disease progression into Class II (special controls), which the agency says will reduce regulatory burdens and help enhance patients' access to the device. The final order is effective July 24, 2026, and FDA notes the classification was applicable on June 29, 2023.
510(k) Premarket Notification Required
FDA states that this prognostic test is subject to premarket notification under section 510(k) of the FD&C Act and that FDA has not determined the device type should be exempt under section 510(m). Manufacturers must therefore submit a 510(k) to market this Class II device.
New Special Controls Set Test Requirements
The final order lists special controls manufacturers must meet, including documented design verification and validation (a clinical study demonstrating performance in intended-use CKD populations with relevant follow-up and subject descriptions), reference interval studies in healthy individuals, precision and interferent assessments where appropriate, and labeling that includes limiting statements (for example: not for diagnosis, not for serial monitoring).
De Novo Creates Predicate for Future Devices
FDA explains that by classifying this device into Class II via the De Novo process, the device can serve as a predicate for future substantially equivalent devices, enabling later sponsors to use the less-burdensome 510(k) pathway rather than De Novo or PMA routes.
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