Including representative and intended users for a human factors (HF) validation test provides invaluable data for manufacturers because participants’ performance data can demonstrate a product’s expected safety and effectiveness once it is in the market. However, it can also be extremely difficult, or nearly impossible, to recruit exact users for a particular product due to the rarity of a condition or job title as well as the person’s health and willingness to participate. In these situations, manufacturers might consider recruiting proxy participants, or substitute participants for actual users. A proxy participant might also be referred to as a surrogate user but will be referred to as a “proxy participant” or “proxy” primarily in this article.
Although regulators generally discourage substituting proxy participants (i.e., proxies) for actual users in HF validation tests of medical devices and combination products, manufacturers might be able to justify including proxies in certain situations. This article explains when it is appropriate to recruit proxies, how to identify an appropriate proxy participant and how to justify including proxy participants in HF validation tests to regulatory bodies.
Proxy Participants in Human Factors Validation Testing
Substituting proxy participants for actual intended users in human factors validation testing
An Emergo by UL Human Factors Specialist discusses when it is acceptable to include proxy (surrogate) participants in HF validation testing, the FDA’s perspective on proxy participants and additional considerations to keep in mind when recruiting proxy p
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