1. (a) Identification. A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.

2. (b) Classification. Class II (special controls). The special controls for this device are:

   1. (1) Design verification and validation must include:

      1. (i) Detailed documentation of a study that demonstrates the clinical performance of the device for its intended use, evaluated across multiple intended use sites and broad demographics representative of intended use patients in the United States; or through an alternative approach determined to be appropriate by FDA;
      2. (ii) Detailed documentation of studies that demonstrate the analytical performance of the device for its intended use, including for each analyte and device output. These studies must include precision, reproducibility, metrological accuracy, and analytical specificity studies, or alternative approaches determined to be appropriate by FDA; and
      3. (iii) As part of the risk management activities, documentation of an appropriate licensed practitioner training program on the proper use of the device and proper interpretation of results that must be offered to licensed practitioners, or an alternative approach determined to be appropriate by FDA.

   2. (2) The labeling required under § 809.10(b) of this chapter must include:

      1. (i) Detailed descriptions of the device studies demonstrating the performance of the device, including results; and

      2. (ii) Limiting statements including the following:

         1. (A) The test result is intended as an aid in the management of the patient, and not to be used to replace clinical judgement.
         2. (B) The test result is not to be used to aid in the diagnosis of preeclampsia or conditions resulting from progression of preeclampsia.
         3. (C) The test result is not to be used to aid in decisions of hospital discharge.
         4. (D) The test result is not to be used to aid in decisions of pregnancy delivery.
         5. (E) The test is not intended to inform the healthcare provider about whether or not changes in immediate treatment, including medication or hospitalization, are needed.

[91 FR 38497, June 26, 2026]