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FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance
May 22 @ 12:00 pm - 1:00 pm
FDA’s Predetermined Change Control Plan (PCCP) Draft Guidance for AI/ML-Enabled Device: Implications and Insights for Regulatory Compliance
Date: Wednesday, May 22, 2024
Time: 12pm – 1pm PT
Audience: Medical device quality assurance, regulatory affairs, and R&D leaders and practitioners.
Platform: Zoom
In April 2023 FDA published its Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions Draft Guidance. There has been much discussion regarding the scope and implications of the draft guidance, and FDA has been actively reviewing PCCPs in submission prior to and since the publication of this document. This session will walk through the contents of the draft guidance highlighting specific recommendations, implications to industry and FDA, and how this guidance might help or hinder an effective regulatory framework for incorporating AI/ML functionality into medical devices.
Learning Objectives:
- Understanding the requirements of FDA’s PCCP for AI/ML draft guidance
- Understanding of the implications of PCCPs for AI/ML-enabled product modifications and submissions
- How the draft guidance may impact FDA’s efforts to establish a regulatory framework for AI/ML-enabled medical devices
Register now to secure your spot and empower your team for success!
About the Speaker:
Eric Henry, Sr. Quality Systems & Compliance Advisor at King & Spalding LLP
Eric is a Senior Quality Systems and Compliance Advisor in the FDA & Life Sciences Practice of the law firm King & Spalding. He is a 35-year industry veteran and since 2018 has provided advisory and consulting services focused on regulatory compliance, enforcement, and policy matters for industries regulated by the FDA. Eric’s guidance focuses on FDA requirements to professionals in medical device manufacturing, including but not limited to quality systems requirements, inspection preparedness and post-market obligations. He also advises corporate management and boards on their responsibilities and expectations of the FDA.
Free to Members
$20 for Nonmembers
Register for your team of 5+ participants? Please email programs@ocra-dg.org.
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