Implementing FDA Guidance for AI in Medical Devices: A Practical Approach

Artificial Intelligence is revolutionizing the development and functionality of medical devices—but with innovation comes regulatory complexity. The FDA has released several key guidance documents that lay the foundation for evaluating and managing AI and Machine Learning (ML) in medical technology.

This Pharmaprofs-exclusive session will break down the FDA’s current guidance, with special focus on:

• Risk-based data support and validation requirements
• Managing bias and promoting equitable outcomes in AI/ML performance
• Increasing transparency in AI decision-making
• Creating and leveraging PCCPs to handle ongoing algorithmic learning and updates
• What has been successfully submitted and approved—and why it worked

Attendees will gain actionable insights, practical tools, and confidence to prepare their AI-enabled technologies for FDA review.

This webinar benefits the following agencies and professionals:

• Medical Device Manufacturers
• AI Software Developers and HealthTech Innovators
• Regulatory Affairs Professionals
• Compliance Officers
• Clinical and Quality Assurance Teams
• Legal and Policy Advisors in Healthcare & Life Sciences

Who Should Attend?

• Regulatory & QA/RA specialists in medtech and digital health
• R&D leaders exploring AI/ML integrations
• Professionals preparing 510(k), de novo, or PMA submissions
• Startups and mid-size firms launching AI-driven healthcare tools
• Legal professionals advising on FDA/AI compliance