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FDA’s Classification of DNA-Based Tests in Hematological Malignancies

May 28, 2025

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...

FDA’s Class II Classification of FISH Devices

May 28, 2025

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...

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