Draft Guidance: Applying Human Factors and Usability Engineering

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FDA has published the Draft Guidance, “Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (June 2011). When final, this document will replace the FDA Guidance “Medical Devices Use-Safety: Incorporating Human Factors Engineering into Risk Management” (published on 18 July 2000).

The guidance suggests what to consider and how to perform appropriate human factors testing on medical devices in order to reduce use error, injury, and prevent recall. The FDA believes that these recommendations will help control current risks and reduce future risks associated with device use.

Read and download the draft guidance here.