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  4. Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance - 04/13/2023
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Webcast | Virtual

Event Title
Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance
April 13, 2023

Date:
April 13, 2023
Time:
1:00 p.m. - 2:30 p.m. ET

Summary

On April 13, 2023, the U.S. Food and Drug Administration (FDA) hosted a webinar for medical device manufacturers and other interested stakeholders to discuss the draft guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The draft guidance includes proposed recommendations for the content to include in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an AI/ML-enabled device. A PCCP outlines anticipated device changes and how those changes will be assessed and implemented in accordance with the PCCP, among other things.

This draft guidance incorporates comments and feedback from the April 2019 Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) discussion paper. The development and release of this draft guidance represents the next step in developing a regulatory framework for AI/ML-based devices as described in the January 2021 FDA's Artificial Intelligence/Machine Learning (AI/ML) Software as a Medical Device Action Plan.

Background

This draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, was issued on April 3, 2023. This draft guidance proposes recommendations for machine learning-enabled device software functions (ML-DSFs) that the manufacturer intends to modify over time.

Webinar Materials

The presentation, printable slides, and transcript are available 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.

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