Stay current on the FDA’s latest requirements for fluorescence in situ hybridization (FISH) devices in hematologic malignancy diagnostics. This focused course explains the new class II (special controls) device classification, outlines the essential regulatory requirements, and details the impact on clinical laboratories and device manufacturers. Gain clarity on documentation, labeling, validation, and risk mitigation steps essential for bringing FISH-based devices to market and ensuring continued patient safety.
In this course you will learn the following:
* Understand the purpose and scope of the FDA’s classification of FISH-based detection devices.
* Identify the key requirements and special controls associated with the classification.
* Recognize the implications for device manufacturers and healthcare providers.
