FDA Webinar Debrief

February 19, 2016

Presenters

CDRH, Human Factors Team

• Shannon Hoste, M.S., Human Factors Pre-Market Evaluation Team Member
• Xin Feng, Ph.D., Human Factors Pre-Market Evaluation Team Member
• Hanniebey Wiyor, Ph.D., Human Factors Pre-Market Evaluation Team Member

Presentation Overview

• Relevant regulations and standards
• FDA’s Human Factors guidance
• List of highest priority devices for human factors review – draft guidance

SLIDES

Human Factors/Usability Engineering

Focuses on interactions between people and devices. The critical element is the device user interface, depicted as the red zone in Figure below

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FDA Human Factors Page

FDA 2016 Guidances

Clarify expectations around when to submit a HF report with a premarket submission

Summarized previously in this blog

Key Takehomes

• Human Factors testing is a part of a robust design control subsystem

• Submit data in premarket submissions if risk analysis indicates user error could result in serious harm

• Consult FDA early using Q-Sub process to discuss and align on development plan and labeling implications

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