This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. For more information on how to subscribe and to activate a complimentary one week trial to Manatt on Health, please reach out to Barret Jefferds.
On January 6, the Food and Drug Administration (FDA) issued two draft guidance documents relating to the use of artificial intelligence (AI) to support development and marketing of medical devices and drugs.
In the guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” FDA lays out its current thinking with respect to the necessary contents of marketing submissions for devices that include AI-enabled software functions—including for the design and development of such devices. The guidance also details recommended strategies for addressing transparency and bias through such means as effective data collection across demographic groups to ensure a device is safe and effective for its intended use in all relevant populations.
In a second guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products,” FDA provides—for the first time—an overview of its thinking on ways in which AI might be used to produce information and data to support marketing applications for drugs. FDA notes the potential for AI to “accelerate the development of safe and effective drugs and enhance patient care” and the corresponding recent increase in reliance upon AI in the context of drug regulatory submissions (such as AI tools used to process and analyze large data sets used to inform clinical trial endpoints or outcome assessments and to better understand disease presentations, etc.).
Even if these guidances are withdrawn or not finalized in the coming months under the incoming Administration, such guidances provide valuable insights into the collective thinking of agency staff and medical product reviewers.
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