FDA’s Classification of Cytomegalovirus Nucleic Acid Detection Device

Explore the FDA’s recent classification of the cytomegalovirus nucleic acid detection device into Class II, highlighting the impact of special controls on safety and access. Gain insights into regulatory compliance and the benefits of reduced regulatory burdens, ensuring quicker access to innovative medical technologies.

In this course you will learn the following:
* Understand the classification process and criteria for the cytomegalovirus nucleic acid detection device.
* Identify the special controls and general controls applicable to the device.
* Recognize the impact of this classification on regulatory burdens and patient access to innovative devices.