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Loeb & Loeb Regulatory partner Kristen Klesh spoke to the Laboratory Economics’ Compliance & Policy Report in a Q&A article about the FDA's endeavors concerning medical products incorporating technology powered by artificial intelligence (AI), given the escalating integration of AI in health care settings.
In the article, Kristen discussed the FDA’s primary focus concerning AI in clinical and anatomic pathology (AP) labs. Additionally, she outlined the actions taken by the FDA to address the incorporation of AI in diagnostic practices.
“The other area the FDA is working on is trying to adjust their existing regulatory framework to keep up with technology that is constantly evolving,” Kristen said. “The FDA has developed an accommodation. Instead of a manufacturer submitting a new 510k market submission every time an algorithm changes, the FDA has said manufacturers should explain in their submission how they developed the algorithm, how it functions and what the potential is for the algorithm to change over time.”
In the article, Kristen discussed the FDA’s primary focus concerning AI in clinical and anatomic pathology (AP) labs. Additionally, she outlined the actions taken by the FDA to address the incorporation of AI in diagnostic practices.
“The other area the FDA is working on is trying to adjust their existing regulatory framework to keep up with technology that is constantly evolving,” Kristen said. “The FDA has developed an accommodation. Instead of a manufacturer submitting a new 510k market submission every time an algorithm changes, the FDA has said manufacturers should explain in their submission how they developed the algorithm, how it functions and what the potential is for the algorithm to change over time.”
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