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...
HHS:Food and Drug Administration
Showing 37–45 of 54 resultsSorted by latest
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FDA Regulation: Clozapine Test System Classification
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FDA Enforcement Policies for Cigarette Health Warnings
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FDA’s Class II Classification: Whole Exome Sequencing Devices
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FDA’s Class II Classification: Blood Collection Device for Cell-Free Nucleic Acids
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FDA’s Class II Classification of Endoscopic Pancreatic Debridement Devices
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FDA’s Classification Impact on Hemodialyzer with Enhanced Solute Removal
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FDA Rule on Hydrophilic Re-Coating Solution Classification
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FDA’s New Classification for Radiofrequency Toothbrushes
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FDA Rule on Class II Medical Devices: Open Loop Fluid Therapy
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