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
A forum to engage with the hosts and other listeners has been launched on the DPA website www.digitalpathologyassociation.org. DPA members may login to the DPA Collaborate hub (under the Resources tab) and join the Beyond The Scope community. All listeners are encouraged to use this forum to suggest future topics and guests, submit questions and corrections, and provide general feedback.
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
A forum to engage with the hosts and other listeners has been launched on the DPA website www.digitalpathologyassociation.org. DPA members may login to the DPA Collaborate hub (under the Resources tab) and join the Beyond The Scope community. All listeners are encouraged to use this forum to suggest future topics and guests, submit questions and corrections, and provide general feedback.