“My company is developing a medical device, and the device includes software that is intended to be used by a clinician to program the therapy for each patient. Before we conduct a clinical trial with patients, we plan to conduct human factors testing with clinicians to ensure that the software is usable. Does this testing require IRB review and approval?”
– CEO, medical device company
Human factors or usability testing plays an important role in the development of medical devices. The application of human factors testing to new medical devices helps the developer minimize the risks and improve the usability of the device by testing its use in a real-world setting.
Most human factors testing for medical devices requires IRB review because the testing is considered by FDA to be a clinical investigation involving human research subjects. In this case, the clinicians participating in the testing are human subjects as defined by the FDA regulations.
Additionally, these investigations require IRB review for FDA to consider the data as part of a marketing permit:
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