Description

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. The FDA has regulated medical device software by means of regulations and guidance for years; however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The objective of AI/ML is to learn and update following deployment using real-world data to improve performance. Thus, the deployed version of the software is no longer the validated approved version. Also, according to the regulation, significant changes require a new 510(k) submission. The objective of AI/ML is to create significant change post-release. A new submission for each update would be impractical.

In January 2025, a draft Guidance explaining the documentation required to obtain clearance/ approval for an AI/ ML product. This training will explain the terminology and the AI/ ML development process,  and explain in detail the procedures described in the draft Guidance. The new requirement, a Predetermined Change Control Program (PCCP), will be explained.

This webinar is not a programming course, but will explain the regulatory requirements for AI/ML

Areas Covered:-

• FDA Discussion Paper on device AI/ML and Action Plan
• AI/ ML process for medical devices
• PCCP
• QC of datasets
• Preliminary Change Control Plan (PCCP)
• Reference standard development
• Standalone performance testing
• Clinical performance testing
• Emphasis on “explainability”
• Cybersecurity.

Why You Should Attend:-

It has not been clear how to get AI/ML programs approved. The regulatory requirements, up to now, don’t control AI/ML adequately.

We will discuss the approaches FDA will take for regulation as described in the  2025 draft Guidance. Necessary submission documentation will be explained, including the new approach of a PCCP.

Who Should Attend:-

• Target Audience :
• Software Engineers
• Engineers
• Regulatory personnel
• Quality Assurance personnel
• Marketing
• Management.