This presentation will explore the intersection of Artificial Intelligence (AI) in medical devices and the FDA’s 510(k) premarket notification process. It will highlight and address the challenges posed by the dynamic nature of AI when compared to traditional regulatory frameworks, particularly regarding device modifications and updates. The presentation will also discuss the use and application of Predetermined Change Control Plans (PCCPs) within device submissions. The presentation will highlight how well-defined PCCPs can streamline the regulatory pathway for AI medical devices by proactively outlining anticipated changes and ensuring patient safety and regulatory oversight. Key considerations for developing robust PCCPs will also be discussed, providing practical insights for manufacturers.
This is the final presentation from day 1 of the live 3-day virtual symposium hosted through the Sotera Academy where Industry experts from Nelson Labs, Sterigenics, and Regulatory Compliance Associates (RCA) take you through a virtual symposium exploring the full product lifecycle of connected and wearable medical devices. From R&D and product design to sterilization, regulatory approval, and launch — this recorded session covers the critical considerations that can make or break the success of your connected device. Click here to watch all of the presentations on the Sotera Academy or fill out the form on this page for access.
