Discover the FDA’s latest classification for devices detecting nucleic acids from non-viral microorganisms causing sexually transmitted infections. This course delves into the specifics of classifying these devices into class II with special controls, aiming to ensure safety and promote innovation while minimizing regulatory challenges. Gain insights into the regulatory landscape and its implications for device manufacturers, healthcare providers, and the broader healthcare industry.
In this course you will learn the following:
* Understand the purpose and scope of the FDA’s classification of these devices.
* Identify the key requirements and special controls associated with class II classification.
* Recognize the implications for device manufacturers and healthcare providers.
