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 Classification of DNA-Based Tests in Hematological Malignancies
$9.99
Explore the intricacies of the FDA’s new classification for DNA-based tests measuring minimal residual disease in hematological malignancies. Learn how the shift to Class II with special controls impacts safety, effectiveness, and patient access, reducing regulatory burdens while maintaining high standards.
In this course you will learn the following:
* Understand the classification process and criteria for the DNA-based test.
* Identify the special controls and general controls applicable to the device.
* Recognize the impact of this classification on regulatory burdens and patient access to innovative devices.
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 DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies. Document Number: 2025-08143 |
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| Course SKU | FR-25-1327-1 |
| Why This Course Is Important | Without this course, you might miss critical insights into the FDA's regulatory landscape affecting the development and deployment of DNA-based diagnostic tests, potentially hindering your ability to align with compliance requirements and leverage market opportunities. |