Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Pipeline Safety: Class Location Change Requirements. Document Number: 2026-00566
Buy this Course
FR-26-1675-1
FDA’s Proposed Reclassification of ISH Test Systems
$49.99
The FDA’s proposal to reclassify in situ hybridization (ISH) test systems from Class III to Class II is set to transform the regulatory landscape for oncology diagnostics. This course offers comprehensive insights into the proposed regulatory framework, the supporting data, and the expected impacts on manufacturers, healthcare providers, and patients. Participants will learn about the special controls necessary for ISH devices and how stakeholder feedback can shape the final ruling.
In this course you will learn the following:
* Understand the purpose and intent of the proposed reclassification.
* Recognize the opportunities for public participation and feedback.
* Identify the potential changes and implications of the proposed rule.
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, potential learners may miss out on understanding the regulatory shifts that could significantly impact product development timelines and market access for oncology 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-25-1393-1