FDA’s Class II Classification of FISH Devices

Learn about the FDA’s critical decision to classify devices for detecting and identifying microbial nucleic acids by FISH into class II, featuring special controls that ensure safety and effectiveness while reducing regulatory burdens. This course covers the implications for manufacturers and healthcare providers, and explains how this classification facilitates access to innovative medical devices.

In this course you will learn the following:
* Understand the purpose and scope of the FDA’s classification of FISH devices.
* Identify the key requirements and special controls associated with class II classification.
* Recognize the implications for device manufacturers and healthcare providers.