FDA published Draft Guidance on Human Factor Studies

The U.S. Food and Drug Administration (FDA) has released draft guidance outlining detailed instructions for conducting use-related risk analyses (URRAs) for drugs, biological products, and combination products. Aimed at both industry and FDA staff, this guidance explains how URRAs support product development and marketing applications by addressing human factors (HF) considerations.

The document emphasizes the importance of URRAs in identifying and mitigating use-related risks early in product development, and throughout the product lifecycle. It includes steps like identifying user tasks, potential errors, clinical risks, and implementing risk controls. It also details submission procedures for URRAs, including justifications for not submitting HF validation study results when appropriate.

Additionally, the guidance provides examples of URRAs in various scenarios, such as pre-filled syringes and emergency auto-injectors. A glossary and appendix are included for reference. The FDA encourages stakeholders to review the draft and submit comments via official channels.