Webcast | Virtual
Event Title
Webinar - Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
January 14, 2025
- Date:
- January 14, 2025
- Time:
- 2:00 p.m. - 3:15 p.m. ET
Summary
On January 14, 2025, the FDA held a webinar for industry and other interested stakeholders to answer questions about the final guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions.
Background
This guidance provides recommendations on the information to include in a Predetermined Change Control Plan (PCCP) in a marketing submission for a device that includes one or more artificial intelligence-enabled device software functions (AI-DSFs). This guidance recommends that a PCCP describe the planned AI-DSF modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications.
This guidance is part of the FDA’s broader commitment to develop and apply innovative approaches to the regulation of device software functions and proposes an approach that would often be least burdensome for manufacturers to support iterative improvement through modifications to an AI-DSF while continuing to provide a reasonable assurance of device safety and effectiveness.
Webinar Materials
The presentation, printable slides, and transcript will be available on this webpage and at CDRH Learn under "Specialty Technical Topics”, sub-section “Digital Health."
If you have questions about this guidance document, please contact the CDRH Digital Health Center of Excellence at digitalhealth@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.