The U.S. Food and Drug Administration (FDA) issued a new draft human factors engineering (HFE) guidance document, Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products, on July 8, 2024. The guidance informs manufacturers of drug- and biologic-led combination products about the purpose and content of a use-related risk analysis (URRA) and how a URRA informs other human factors (HF) activities and can be used to support a marketing application or justification to forgo submitting HF validation study results. The benefit of this new draft guidance is that it organizes and consolidates all risk analysis information into one document. This article summarizes Emergo by UL’s interpretation of the guidance and describes the key content needed for a strong URRA and justifications to forgo submitting HF validation study results.
Summary of FDA July 2024 Draft Guidance on URRAs | Emergo by UL
New FDA Guidance: Use-Related Risk Analyses for Drugs, Biological Products and Combination Products
Emergo by UL human factors specialists share insights into recent U.S. Food and Drug Administration (FDA) draft guidance on the purpose and content of URRAs for drugs and medical products.
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