FDA Clears Path for New Preeclampsia Risk Test
Published Date: 6/26/2026
Rule
Summary
The FDA is officially putting the test that predicts preeclampsia risk into a safer, easier-to-get category called Class II. This change helps make sure the test works well and is safe, while also making it simpler for patients to access this important health tool. The new rules took effect on June 26, 2026, but the classification has been in place since May 18, 2023, helping companies save time and money on approvals.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Preeclampsia Test Moved to Class II
The FDA has classified the prognostic test for development or progression of preeclampsia into Class II (special controls). The order is effective June 26, 2026, and the classification has been applicable since May 18, 2023, which FDA says will reduce regulatory burdens and enhance patient access to the test.
Manufacturers Must Meet Study Requirements
Companies that make this prognostic test must provide detailed documentation of clinical performance studies across multiple intended-use sites and broad U.S. demographics, analytical performance studies (precision, reproducibility, metrological accuracy, analytical specificity), and documentation of a practitioner training program. The device remains subject to premarket notification under section 510(k).
Creates Predicate Pathway for Future Tests
Because the device was classified into Class II via the De Novo process, it can serve as a predicate device, allowing future similar devices to use the less burdensome 510(k) process rather than De Novo or premarket approval. FDA notes this can reduce regulatory burdens for subsequent device sponsors.
Labeling Must Limit Clinical Use
Labeling must include study results and limiting statements that the test is an aid in risk assessment and not intended for diagnosis, hospital discharge decisions, delivery decisions, or to inform immediate treatment changes including medication or hospitalization. These limits define how clinicians may use test results in patient care.
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