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The course you are looking at is not like any other e-Learning course you have ever taken. Watch this short video to learn why!

FDA’s Class II Classification: Whole Exome Sequencing Devices

$9.99

Discover the significant implications of the FDA’s decision to classify whole exome sequencing devices into Class II with special controls. This course provides comprehensive insights into the regulatory framework and what it means for the safety, effectiveness, and innovation in the field of medical devices.

In this course you will learn the following:
* Understand the classification process and criteria for the whole exome sequencing constituent device.
* Identify the special controls required for compliance.
* Recognize the potential risks and mitigation measures associated with the device.

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”. 

SKU: FR-24-228-1 Categories: , , , , , Tags: , Course: FDA’s Class II Classification: Whole Exome Sequencing Devices
SKU: FR-24-228-1 Categories: , , , , , Tags: , Course: FDA’s Class II Classification: Whole Exome Sequencing Devices

Why This Course is Important
Without this course, learners risk misunderstanding the critical compliance requirements, possibly resulting in regulatory setbacks and limited market access for new medical technologies.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device.

Key regulatory references include:

Course SKU
FR-24-228-1

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