$9.99
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.
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, professionals risk non-compliance with FDA device regulations, potentially delaying device approval, missing out on streamlined market access, and failing to implement critical safety measures that protect patients and support innovative diagnostics.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies.
Key regulatory references include:
Course SKU
FR-25-1406-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Federal Acquisition Regulation: Prohibition on Certain Semiconductor Products and Services. Document Number: 2026-03065
Buy this Course
FR-26-1735-1
Why This Course is Important
Failure to take this course could leave you unprepared for significant contract compliance changes, risking loss of contract eligibility and exposure to penalties for non-compliance with upcoming federal semiconductor procurement prohibitions.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Federal Acquisition Regulation: Prohibition on Certain Semiconductor Products and Services.
Key regulatory references include:
Course SKU
FR-26-1735-1
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