FDA Oversight of Laboratory-Developed Tests: Is It Necessary, and How Would It Impact Clinical Laboratories?
Clinical Chemistry Podcast · Association for Diagnostics and Laboratory Medicine
July 30, 201310m 57s
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Show Notes
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.