The Next Clinical Decision Frontier: How to Efficiently and Safely Combine Machine Learning and Human Expertise
Clinical Chemistry Podcast
enMarch 06, 2024
The US Food and Drug Administration has long maintained its right to regulate LDTs; however until recently they've chosen to exercise discretion and have left this to the individual laboratories and other regulatory agencies. This is now in a state of change, and the FDA has stated that it would issue guidance on its oversight of Laboratory Developed Tests.
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