Why This Course is Important
Without this course, you risk missing critical FDA requirements, potentially facing costly enforcement actions, market delays, or loss of U.S. market access for your innovative medical imaging software.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan.
Key regulatory references include:
Course SKU
FR-26-2005-1