Gain expert insight into the FDA’s new classification for prognostic tests that assess chronic kidney disease (CKD) progression. This course details the specific regulatory requirements, including special controls and labeling standards, for Class II devices. Learn actionable steps for compliance, clinical validation, and the potential risks of non-compliance. Essential for manufacturers and stakeholders involved in CKD diagnostic technology, this training ensures your products meet both safety and legal standards for market access.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying CKD prognostic tests as class II devices.
* Identify the special controls and general controls required for compliance.
* Implement the necessary design, validation, and labeling requirements.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
