Transitioning to FDA’s New Premarket Submission Guidance: Impact on Quality Systems and Development Practices

On June 14, 2023, FDA released the Content of Premarket Submissions for Device Software Functions replacing the 2005 version, which defined the content of software submissions. The recent update brings significant changes to the submission process, particularly in the levels of documentation required based on the risk level of the device.

Led by the founder of the FDA software engineering lab Paul Jones and former head of AI/ML for Amgen’s medical device division Erez Kaminski, this webinar will provide large and established quality and product teams with crucial guidance information and practical steps for achieving compliance.

What you'll learn

• Understand the key changes brought about by the new FDA Premarket Submission Guidance and its significance to medical device and SaMD manufacturers.
• Explore the interplay between the new premarket submission guidance and other related regulations, such as eSTAR, the Software Bill of Materials (SBOM) requirement, and use of AI/ML Predetermined Change Control Plans (PCCP).
• Identify practical steps and strategies for adapting your Software Development Life Cycle (SDLC) practices to align with the recent regulatory changes.
• Gain insights into how these regulatory updates can positively impact your product development and quality assurance processes, ultimately leading to safer and more effective software.

Who should attend

• Quality and Regulatory professionals
• Development managers and executives

Clips from this Webinar

1. How to prepare for new FDA premarket submission guidance - 1:28
2. Change in Categories of Level of Concern - 3:01

Speakers

Paul Jones

VP of RA/QA
Ketryx

Erez Kaminski

Founder & CEO
Ketryx