What are the IRB review requirements for human factors/usability testing?

Question:

“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

Response:

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:

“Except as provided in §§ 56.104 and 56.105, the Food and Drug Administration may decide not to consider in support of an application for a research or marketing permit any data or information that has been derived from a clinical investigation that has not been approved by, and that was not subject to initial and continuing review by, an IRB meeting the requirements of this part.”

FDA, 21 CFR 56.103(B)