FDA Regulation of Artificial Intelligence - Machine Learning

The FDA is crucial in regulating artificial intelligence and machine learning technologies, especially in healthcare. These regulations aim to ensure the safety, effectiveness, and reliability of AI/ML-based medical devices and software.

AI/ML applications in healthcare, the FDA provides guidance and oversight to companies developing these technologies. They evaluate how these innovations are used in medical devices, diagnostics, software, and decision support systems. The focus is on ensuring these technologies meet specific safety standards before being marketed and used in healthcare settings.

The webinar will address the current regulatory requirements, how they don't control AI/ML adequately, and approaches the FDA is considering for regulation soon. Attendees will receive a multipage outline and checklist.

Webinar Highlights:

• The webinar will discuss the total product life cycle approach to AI/ ML design.
• Understanding application of FDA software Pre-Cert program to AI/ ML.
• The webinar will discuss the FDA paper on AI/ML.
• To fully realize the power of AI/ML learning algorithms while enabling continuous performance improvement.
• The webinar provides an easy framework for setting a dataset's quality control workflow.
• Database Management systems allow complex queries and extensive analysis.
• The webinar will provide increased transparency to users and the FDA using post-market real-world performance reporting to maintain continued safety and effectiveness assurance. 
• Participants will be updated regarding the algorithm.
• The webinar will explore reference standard development.
• Attendees will get guidance on standalone performance testing and clinical performance testing.
• A brief discussion on data enrichment.
• Participants will explore methods and additional labeling requirements.
• Dealing with cybersecurity and protecting systems, networks, and programs from digital attacks.

Why Should You Attend:

The field of AI/ML continues to evolve, and the FDA regularly updates its guidance and regulations to keep in step with technological advancement while ensuring patient safety and product effectiveness. The webinar will discuss the approaches the FDA is considering for regulation soon and how to get the AI/ML program approved by the FDA. 

Who Should Attend:

• Marketing
• Management
• Software Engineers
• Regulatory personnel
• Quality Assurance personnel