AI is expected to change healthcare, but it brings risks around ethical data use, biased algorithms, patient safety and cybersecurity. FDA has started overseeing AI/ML-enabled device software functions, and its recommendations center on a predetermined change control plan (PCCP) in the marketing submission.
This 75-minute webinar explains what a PCCP is and what it should contain: the types of modifications to include, the modification protocol, traceability and impact assessment for changes to machine learning models and algorithms.
You'll also look at data management and retraining practices, performance evaluation protocols and update procedures. Device examples and hypothetical scenarios show when a model change stays within an authorized PCCP and when a new marketing submission is needed.
WHY SHOULD YOU ATTEND?
A growing number of AI/ML-enabled devices, many in radiology, have FDA authorization. Manufacturers that anticipate post-approval changes in an authorized PCCP don't need a new submission for those changes, which saves time and cost.
The session suits regulatory affairs professionals, engineers, developers, executives and founders at AI and medical device companies, as well as researchers and students who want to understand FDA's expectations and the AI Bill of Rights.
AREA COVERED
- Machine learning, AI and AI/ML device software functions
- The AI Bill of Rights and design and development considerations for AI/ML software
- Marketing submission considerations for an FDA-recommended predetermined change control plan (PCCP)
- Types of modifications to include in a PCCP
- PCCP contents
- Modification protocol, traceability and impact assessment for changes to ML models and algorithms
- Data management, retraining, performance evaluation protocols and update procedures
- Device examples and hypothetical scenarios: compliant modifications vs a new marketing submission
LEARNING OBJECTIVES
- Explain why FDA expects a PCCP in marketing submissions for AI/ML device software
- Identify the types of modifications that belong in a PCCP
- Describe the contents of a PCCP, including the modification protocol and impact assessment
- Plan data management and retraining practices for ML device software functions
- Set up performance evaluation protocols and update procedures
- Tell when a model change is covered by an authorized PCCP and when a new submission is needed
WHO WILL BENEFIT?
- AI software companies in the medical device industry – executives, entrepreneurs, engineers, developers, programmers, research & development personnel
- Medical device companies – executives, entrepreneurs, engineers, developers, programmers, research & development personnel
- Regulatory Affairs Professionals in medical device and AI companies
- Software engineers, biomedical engineers, software developers, programmers,
- IT personnel of AI machine learning software
- AI researchers and students at universities
- Students in regulatory programs
A growing number of AI/ML-enabled devices, many in radiology, have FDA authorization. Manufacturers that anticipate post-approval changes in an authorized PCCP don't need a new submission for those changes, which saves time and cost.
The session suits regulatory affairs professionals, engineers, developers, executives and founders at AI and medical device companies, as well as researchers and students who want to understand FDA's expectations and the AI Bill of Rights.
- Machine learning, AI and AI/ML device software functions
- The AI Bill of Rights and design and development considerations for AI/ML software
- Marketing submission considerations for an FDA-recommended predetermined change control plan (PCCP)
- Types of modifications to include in a PCCP
- PCCP contents
- Modification protocol, traceability and impact assessment for changes to ML models and algorithms
- Data management, retraining, performance evaluation protocols and update procedures
- Device examples and hypothetical scenarios: compliant modifications vs a new marketing submission
- Explain why FDA expects a PCCP in marketing submissions for AI/ML device software
- Identify the types of modifications that belong in a PCCP
- Describe the contents of a PCCP, including the modification protocol and impact assessment
- Plan data management and retraining practices for ML device software functions
- Set up performance evaluation protocols and update procedures
- Tell when a model change is covered by an authorized PCCP and when a new submission is needed
- AI software companies in the medical device industry – executives, entrepreneurs, engineers, developers, programmers, research & development personnel
- Medical device companies – executives, entrepreneurs, engineers, developers, programmers, research & development personnel
- Regulatory Affairs Professionals in medical device and AI companies
- Software engineers, biomedical engineers, software developers, programmers,
- IT personnel of AI machine learning software
- AI researchers and students at universities
- Students in regulatory programs