Prepare your organization for the FDA’s new regulatory environment governing in situ hybridization (ISH) test systems for oncology therapeutics. This course delivers a structured approach to meeting all requirements stemming from the FDA’s final rule: transitioning ISH systems from Class III (PMA) to Class II (special controls), navigating the 510(k) process, meeting rigorous design and labeling standards, and avoiding legal and financial consequences. Targeted for regulatory affairs professionals, device manufacturers, and quality managers.
In this course you will learn the following:
* Understand the regulatory background and rationale for the reclassification.
* Identify the new classification and special controls for ISH test systems.
* Implement the required design, validation, and labeling controls.
* Navigate the 510(k) premarket notification process for these devices.
* Recognize the legal and financial consequences of non-compliance.
