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In January 2025, a draft Guidance explaining the documentation required to obtain clearance/ approval for an AI/ ML product.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will explain the terminology and the AI/ ML development process, and explain in detail the procedures described in the draft Guidance.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We will discuss the approaches FDA will take for regulation as described in the 2025 draft Guidance.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.
Order Now!
Edwin Waldbusser is a consultant who retired from the industry after 20 years in the management of the development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis, and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.
