{"id":5929,"date":"2025-12-04T00:34:21","date_gmt":"2025-12-04T00:34:21","guid":{"rendered":"https:\/\/www.gilero.com\/?p=4286"},"modified":"2026-08-28T18:00:25","modified_gmt":"2026-08-28T18:00:25","slug":"human-factors-validation","status":"publish","type":"blog","link":"https:\/\/www.sanner-group.com\/insights\/blog\/human-factors-validation\/","title":{"rendered":"How Do I Know When a Human Factors Validation Is Needed?"},"content":{"rendered":"\n
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So, you’re working on a new medical device or combination product.<\/strong><\/h2>\n

You may need human factors testing to bring this product to market. You\u2019ll find yourself in one of two groups:<\/p>\n

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  1. My product will require human factors validation (HFV) testing; or<\/li>\n
  2. I can justify not performing HFV testing.<\/li>\n<\/ol>\n

     <\/p>\n

    Which path do I pursue?<\/strong><\/h2>\n

    So how do you know which path to pursue? Historically this was largely based on your regulatory path. For example, if pursuing an ANDA, you likely were not too concerned about performing HFV testing.<\/p>\n

    However, the current guidance from the FDA is that this will come down to the risk associated with your specific product. HFV will be determined based on your product\u2019s use risk and whatever equivalency claims can you justify to a comparable product. For those who may be unfamiliar with the human factors process, use risk is the risk your product poses to its users as a result of them interacting with its interface. The FDA details their preference for how to analyze use risk in their guidance document Purpose and content of use-related risk analyses for drugs, biological product, and combination products<\/a>.<\/p>\n

     <\/p>\n

    Use Related Risk Analysis (URRA)<\/strong><\/h2>\n

    If you need more assistance on how to draft a URRA, I recommend reviewing Greenlight Guru\u2019s free webinar Use related risk analysis & how it applies to medical device development.<\/a> In this webinar my colleague and I provide a detailed overview of both the theory behind a URRA and its construction.<\/p>\n

    So let\u2019s assume you have completed your URRA; what now? The results of the URRA will have identified that your product either:<\/p>\n