FDA Executive Summary For The Digital Heath Advisory Committee Meeting: Total Product Lifecycle Considerations for Generative AI-Enabled Devices (Nov 2024)
In a risk-adverse world, adopting generative AI may seem like a daunting task. FDA’s recently published “Executive Summary For The Digital Heath Advisory Committee Meeting: Total Product Lifecycle Considerations for Generative AI-Enabled Devices“ (Nov 2024) provides clarity on what organizations can expect from FDA’s regulatory oversight of generative AI.
Notably, FDA does not intend rigorous oversight for generative AI used for administrative functions:
“There is a broad range of current and potential implementations of GenAI in health care; some of these implementations form products that are medical devices, while others are not within FDA’s jurisdiction. These implementations may include administrative functions, such as facilitating clinical documentation“
This should be good news for organizations seeking to leverage generative AI for operational efficiency and quality gains.
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As drug development experts in the AI space, we provide consulting to organizations considering use of generative AI – visit our website at www.waterworksai.com to schedule a free discovery call.