The Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the prognostic test for development or progression of preeclampsia. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
US Federal Register - FDA Rules · June 26, 2026
FDA Classification of Prognostic Test for Development or Progression of Preeclampsia as Class II
Original title: Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
FDA classifies prognostic test for preeclampsia development or progression into class II with special controls.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.