Stay up to date with the latest FDA regulatory requirements affecting prognostic tests for preeclampsia. This course provides detailed guidance on compliance with the final rule classifying these tests as class II medical devices, including mandatory design, validation, labeling, and practitioner training steps. Learn what it takes to bring innovative preeclampsia risk assessment devices to market, minimize regulatory risk, and ensure product safety and effectiveness.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the prognostic test for preeclampsia as class II.
* Identify the special controls and general controls applicable to this device type.
* Implement the required design, validation, labeling, and practitioner training measures.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
