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FDA Classification of Radiological CAD Software into Class II

$19.99

Gain a comprehensive understanding of the FDA’s classification of radiological computer-assisted detection and diagnosis software into class II. Explore the special controls established to ensure safety and effectiveness, and learn how these regulations impact patient access to innovative devices.

In this course you will learn the following:
* Understand the classification of radiological computer-assisted detection and diagnosis software into class II.
* Identify the special controls required for compliance.
* Recognize the impact of this classification on regulatory processes and patient access to innovative devices.

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
Potential learners risk misunderstanding the specific regulatory requirements and special controls necessary for ensuring the safety and effectiveness of radiological CAD software, potentially leading to non-compliance and legal repercussions.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software.

Key regulatory references include:

Course SKU
FR-25-1390-1