 
Today, the U.S. Food and Drug Administration (FDA) issued final guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
This guidance is intended to provide a forward-thinking approach to promote the development of safe and effective AI-enabled devices. Additionally, this guidance provides the FDA’s current thinking on predetermined change control plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for an AI-enabled device software function (AI-DSF).
This final guidance:
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Represents the FDA’s next step in working to develop a tailored regulatory approach for AI-DSFs.
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Demonstrates the FDA’s broader commitment to develop and apply innovative approaches to the regulation of device software functions.
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Affirms that digital health technologies should be designed and targeted to meet the needs of diverse populations.
Upcoming webinar on this guidance
On January 14, 2025, the FDA will host a webinar for industry and others interested in learning more about the final guidance.
Questions?
If you have questions about this final guidance, contact the Digital Health Center of Excellence. If you have questions about the webinar, contact the Division of Industry and Consumer Education.
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