TAG:
medical device
FDA Has Future Avenues to LDT Oversight
CEO SUMMARY: Even though a federal court vacated the FDA’s final rule for laboratory developed tests, experts warn that the agency may still be able to regulate some LDTs via its authority over diagnostic software. An attorney notes that software’s central role in mode…
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Volume XXXII, No. 15 – October 27, 2025
The Dark Report examines the momentous decision by the VA to switch accreditors from The Joint Commission to CAP. Also, we analyze retractions in pathology journals to gain insight into scientific fraud.
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