The FDA human factors guidance describes how critical tasks should be defined. Manufacturers sometimes forget that critical tasks also include those that, if not performed correctly, result in compromised care. It may be considered a significant risk if the drug or device cannot serve its intended purpose due to usability issues. The FDA guidance provides a description of how to conduct simulated use usability testing starting on page 20.
https://www.fda.gov/downloads/UCM259760.pdfIn regards to your question about IRB approval, it is good practice to consult an IRB when human subjects are involved. If the study is as you describe, with very low risk to the participant, the IRB will likely determine the study to be exempt from requiring approval. You will want all participants to sign an informed consent form. The informed consent should tell them all they will encounter in the study, any potential risk they may be exposed to, release to video record (if applicable), and an explanation about how their identity will remain confidential.
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Bryant Foster - Director of Research
Research Collective - The Human Factors Experts
www.Research-Collective.comBryant@Research-Collective.com------------------------------
Original Message:
Sent: 19-Nov-2017 09:41
From: Tessa Lebinger
Subject: Human Factors testing
I am looking for a practical guide to human factors testing for non significant risk devices to be regulated under 510(k) - either one of the standards or another publication. Also, does anyone know in the US if you need to get IRB approval and obtain consent to test subjects' understanding of the user guide, ability to use buttons on a screen, understand error messages, etc if the device is not actually in use (but the results of the human factors testing will be used to support the 510(k) submission) Thank you