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.
FDA’s Classification of DNA-Based Tests in Hematological Malignancies
$9.99
1 year of access
Course Content
FDA’s Classification of DNA-Based Tests in Hematological Malignancies
