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.
FDA’s Class II Classification: Whole Exome Sequencing Devices
$9.99
1 year of access
Course Content
FDA’s Class II Classification: Whole Exome Sequencing Devices
