Navigating Regulatory Challenges for LDTs

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Staci Kearney PhD is the founder and CEO of Elevation Strategic Consulting, a firm that provides regulatory assistance to digital pathology companies. In May 2024, The FDA ruled that Laboratory Developed Tests (LDTs) will be regulated as medical devices with FDA oversight in the coming years. Staci joins for a special episode to break down the timeline for vendors to be compliant with the new rule and implications for digital pathology companies and laboratories.

Laboratory Developed Tests-Frequently Asked Questions-FDA

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