Gain a comprehensive understanding of the FDA’s recent classification of microbial nucleic acid storage and stabilization devices into Class II with special controls. This course highlights the significance of these controls in ensuring device safety and effectiveness, while also reducing regulatory burdens. Equip yourself with the knowledge to navigate this regulatory shift and enhance access to innovative medical solutions.
In this course you will learn the following:
* Understand the classification process and criteria for the microbial nucleic acid storage and stabilization device.
* Identify the special controls required for compliance.
* Recognize the impact of this classification on regulatory burdens and patient access to innovative devices.
