Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
Key claim: The FDA is classifying the prognostic test for development or progression of preeclampsia as a class II medical device subject to special controls, providing a regulatory framework that assures safety and effectiveness while enhancing patient access.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Classifying the preeclampsia prognostic test as Class II with special controls creates a defined FDA pathway for future manufacturers, potentially expanding clinician access to risk-stratification tools during pregnancy. For patients and providers, this can shape which tests are available to guide monitoring and intervention decisions for a leading cause of maternal morbidity.