Stay ahead of regulatory changes with this essential course covering the FDA’s final rule classifying liver iron concentration imaging companion diagnostics for deferasirox as class II devices with special controls. The training provides manufacturers, sponsors, and regulatory professionals with a step-by-step guide to compliance, including performance testing, labeling, and premarket submission requirements. Learn the specific obligations to ensure your device meets FDA standards, maintains market access, and optimizes patient outcomes in non-transfusion-dependent thalassemia management.
In this course you will learn the following:
* Understand the FDA’s classification process for new medical devices, specifically the De Novo pathway.
* Identify the key requirements and special controls for the liver iron concentration imaging companion diagnostic for deferasirox.
* Implement the necessary steps to ensure compliance with the new classification and special controls.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
