# 2026-12900: FDA Clears Path for New Preeclampsia Risk Test

2026-12900, Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-26, effective 2026-06-26; PRIA reads it as touching household money (as of 2026-07-03).

- Canonical: https://policyrisk.com/federal-register/2026-12900
- As of: 2026-07-03
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12900
- Title: Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 38496
- Published: 2026-06-26
- Effective: 2026-06-26
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-07-03

## In one line

FDA Clears Path for New Preeclampsia Risk Test

## 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.

## Abstract

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.

## Effects PRIA read

- Preeclampsia Test Moved to Class II: benefit, medium. 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 t…
- Manufacturers Must Meet Study Requirements: cost, medium. 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…
- Labeling Must Limit Clinical Use: benefit, low. 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 clinicia…
- Creates Predicate Pathway for Future Tests: benefit, medium. 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 sponso…

## Related documents

- [2026-20848](https://policyrisk.com/federal-register/2026-20848): Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods, 2026-10-13
- [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11
- [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13
- [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29
- [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25
- [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27

## Sources
- [2026-12900 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/26/2026-12900/medical-devices-clinical-chemistry-and-toxicology-devices-classification-of-the-prognostic-test-for)
- [2026-12900 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-26/pdf/2026-12900.pdf)

## Related
- [Previous: 2026-12899, Medical Devices; General Hospital and Personal Use Devices; Classification of t…](https://policyrisk.com/federal-register/2026-12899)
- [Next: 2026-12901, Medical Devices; Neurological Devices; Classification of the Computerized Behav…](https://policyrisk.com/federal-register/2026-12901)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12900 (as of 2026-07-03).