The document discusses regulatory frameworks for artificial intelligence and machine learning in software as medical devices. It provides definitions of artificial intelligence and machine learning, and examples of their applications in imaging and electrocardiogram devices. It also outlines the International Medical Device Regulators Forum risk categorization for software as a medical device, the FDA's total product lifecycle approach, components of a clinical evaluation and algorithm change protocol. The presentation concludes with a flowchart approach for modifications to previously approved software as a medical device.

1. Regulatory Framework
Artificial Intelligence and Machine Learning in
Software as a Medical Device
Yuan Song
Professor, Data Scientist
Duke University
1Copyright by Bigfish HealthAug. 2019

2. DISCLAIMER
The views and opinions presented represent those of the
speaker and should not be considered to represent advice
or guidance on behalf of the Food and Drug Administration.
Copyright by Bigfish Health 2Aug. 2019

3. Artificial Intelligence
• science and engineering of making intelligent
machines, especially intelligent computer
programs (McCarthy, 2007).
• Artificial intelligence can use different
techniques, including models based on statistical
analysis of data, expert systems that primarily
rely on if-then statements, and machine
learning.
Copyright by Bigfish Health 3Aug. 2019

4. Machine
Learning
Copyright by Bigfish Health 4
an artificial intelligence technique that can be used to design and train
software algorithms to learn from and act on data.
Software developers can use machine learning to create an algorithm
that is ‘locked’ so that its function does not change, or ‘adaptive’ so its
behavior can change over time based on new data.
Some real-world examples of artificial intelligence and machine
learning technologies include:
An imaging system that uses algorithms to give diagnostic information
for skin cancer in patients.
A smart electrocardiogram (ECG) device that estimates the probability
of a heart attack.
Aug. 2019

5. SaMD IMDRF risk categorization
Copyright by Bigfish Health 5
Aug. 2019

6. Overlay of
FDA's TPLC
approach on
AI/ML
workflow
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7. IMDRF description of Clinical Evaluation
components
Aug. 2019

8. Algorithm
Change
Protocol
components
Copyright by Bigfish Health 8Aug. 2019

9. Approach to
modifications to
previously approved
SaMD with SPS and
ACP. This flowchart
should only be
considered in
conjunction with the
accompanying text in
this white paper.
Copyright by Bigfish Health 9Aug. 2019

10. Copyright by Bigfish Health 10
Thank you
Q&A
Aug. 2019