FDA Webinar Debrief

February 19, 2016

HFE

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  • List of highest priority devices for human factors review – draft guidance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

.user interface.JPG

FDA Human Factors Page

FDA 2016 Guidances

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

HFE3human factors

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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