On June 26, 2026, the FDA issued a Federal Register notice classifying the 'prognostic test for development or progression of preeclampsia' into device Class II with special controls, per the agency's notice. Classification sounds technical, but it answers a practical question: what standard must a preeclampsia risk blood test meet before it can be marketed in the United States. This site publishes information, not medical advice; if you are pregnant and have concerning symptoms, contact your own clinician without waiting for test developments.
What preeclampsia is, and what these tests do
Preeclampsia is a pregnancy complication in which high blood pressure develops alongside signs of organ stress — most often liver or kidneys — typically after 20 weeks of gestation. It is a leading cause of maternal and infant illness, per CDC maternal health data. The tests in question do not diagnose it; they estimate risk of progression in women who already show warning signs. The first such assays cleared in the US — Thermo Fisher Scientific's B·R·A·H·M·S sFlt-1 and PlGF Plus KRYPTOR immunoassays, cleared in May 2023 per the Preeclampsia Foundation — measure two proteins whose ratio helps predict severe disease within the following two weeks in hospitalized preterm patients.
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What Class II with special controls means
FDA device classification sorts tests by risk and by the controls needed to assure accuracy. Class II with special controls means a manufacturer can clear a future preeclampsia prognostic test through the standard 510(k) route — demonstrating similarity to an existing cleared test — provided it meets the agency's specified performance requirements, per the June 26, 2026 notice. Before this classification, each new entrant faced a less predictable path. The practical effect should be more tests competing in the category, and clearer labeling about what a risk score can and cannot tell a pregnant patient.
What it means in a pregnancy
Nothing here is a screening test for routine prenatal visits yet. As currently cleared, the assays apply to women already hospitalized or under evaluation for suspected preeclampsia in the preterm window — they help clinicians decide how urgently to escalate monitoring, corticosteroids for fetal lung maturity, or delivery, per the cleared labeling. Routine outpatient prediction of who will develop preeclampsia remains an open research problem, and no test currently replaces the standard care of blood pressure checks and lab monitoring.
The context most coverage skipped
The US is late to formalize this category: risk-stratifying ratio tests for suspected preeclampsia have been routine in the United Kingdom and much of Europe since around 2016, guided by NICE diagnostics guidance. The FDA's classification is less a scientific breakthrough than an infrastructure decision — and its most important consequence may be on the margins of the notice, where the agency defines the evidence a future first-trimester or outpatient predictive test would need. That definition will shape whether preeclampsia prediction becomes a routine prenatal tool or stays a hospital test.