Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Regulation Crypto Assets. Document Number: 2026-17183
Buy this Course
FR-26-2164-1
FDA Requirements for Prognostic Tests Assessing Chronic Kidney Disease Progression
$9.99
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.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Why This Course is Important
Without this training, you may miss critical FDA requirements, risk costly delays, or face legal penalties that could prevent your CKD prognostic tests from entering the market.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression.
Key regulatory references include:
Course SKU
FR-26-2107-1