Discover how the final rule from the CDC expands access to the World Trade Center (WTC) Health Program, now including Pentagon and Shanksville responders. This course unpacks the statutory changes, capped at 500 new enrollees, detailing the impact and compliance with...
FDA’s Class II Classification of FISH Devices
$9.99
Learn about the FDA’s critical decision to classify devices for detecting and identifying microbial nucleic acids by FISH into class II, featuring special controls that ensure safety and effectiveness while reducing regulatory burdens. This course covers the implications for manufacturers and healthcare providers, and explains how this classification facilitates access to innovative medical devices.
In this course you will learn the following:
* Understand the purpose and scope of the FDA’s classification of FISH devices.
* Identify the key requirements and special controls associated with class II 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”.
Additional information
| Federal Register Title | Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens. Document Number: 2025-08150 |
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| Course SKU | FR-25-1326-1 |
| Why This Course Is Important | If you skip this course, you may miss out on understanding how the FDA's classification impacts device safety, innovation, and regulatory processes. |