After an over decade-long discourse amongst interested stakeholders, on October 3, 2023, FDA unveiled its proposed rule and policy to increase oversight over LDTs. If finalized as proposed, FDA would ...
A laboratory director of a nonwaived lab who holds a doctor of medicine (MD) or doctor of osteopathy (DO) degree must also be certified in anatomic pathology or clinical pathology, or both, by the ...
Clinical genomics laboratories are no longer limited to research settings; they are increasingly integrated into routine pathology and clinical testing environments. As sequencing technologies mature ...
Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical ...
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