Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
What happened
The Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia into class II, with special controls. This action, signed by Donald Trump and effective June 26, 2026, aims to ensure the device's safety and effectiveness while reducing regulatory burdens. The classification was applicable on May 18, 2023.
Why it matters
By placing this preeclampsia test into a lower risk class, the FDA believes more patients will gain access to this beneficial and innovative device. This move also simplifies the regulatory process for other similar tests, encouraging faster development and availability in the future.
Who it affects
- ›Patients at risk of preeclampsia
- ›Medical device manufacturers
- ›Healthcare providers
- ›Food and Drug Administration (FDA)
The receipts are official. The summary is ours.
Read on Federal Register ↗Summaries are generated from the official text and may simplify or omit nuance. The official document is the source of truth.