Stay ahead of evolving FDA regulations with this course on the classification and compliance requirements for radiological machine learning-based quantitative imaging software with a predetermined change control plan (PCCP). Discover the specific special controls, technical documentation standards, risk management protocols, and labeling obligations needed to achieve and maintain Class II status. Gain practical knowledge for preparing your 510(k) submissions, supporting innovation, and ensuring both patient safety and continued market access.
In this course you will learn the following:
* Understand the scope and intent of the FDA’s final classification order.
* Identify the key requirements and special controls for class II radiological machine learning-based quantitative imaging software with PCCP.
* Implement the necessary steps to ensure compliance with the new regulatory requirements.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
