FDA Classification of Radiology Software for Fibrotic Lung Disease
Gain critical insights into the FDA’s new rule classifying radiology software for fibrotic lung disease as class II (special controls). This course covers compliance steps for manufacturers, from 510(k) submissions to implementing clinical validation, software verification, and detailed labeling. Learn the specific requirements, timelines, and consequences of non-compliance so your organization can maintain market access and ensure patient safety when developing or using these medical devices.
In this course you will learn the following:
* Understand the FDA’s classification of radiology software for fibrotic lung disease and its implications.
* Identify and implement the special controls required for compliance.
* Recognize the risks associated with these devices and the required mitigation measures.
* Comply with premarket notification (510(k)) and labeling requirements.
* Understand the legal and regulatory consequences of non-compliance.
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”.
