Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Regulation Crypto Assets. Document Number: 2026-17183
Buy this Course
FR-26-2164-1
FDA Reclassification of In Situ Hybridization (ISH) Test Systems for Oncology Therapeutics: Compliance and Implementation Training
$129.99
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.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
Why This Course is Important
Without this course, you risk regulatory non-compliance, potential delays in product launches, and missed opportunities to streamline market access for oncology ISH diagnostics.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product.
Key regulatory references include:
Course SKU
FR-26-2154-1