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IRB Approval For Human Factors Testing Is A "Judgment Call" For US Device Makers

This article was originally published in SRA

Executive Summary

Sponsors of medical devices and combination products in the US who are required to submit human factors data to the Food and Drug Administration should take a cautious approach when deciding whether approval of an institutional review board (IRB) is needed for carrying out usability studies as there is no clear guidance on this topic.

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