FDA Draft Guidance on Medical Device Design

On Wednesday, the Food and Drug Administration (FDA) released “Draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design” (.pdf).

According to the document, the:

“FDA has developed this draft guidance document to assist industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.” (p. 4)

Moreover, it states:

“This guidance provides recommendations for medical device design optimization through human factors analysis, testing and validation. The intent is to improve the quality of the device user interface such that errors that occur during use of the device are either eliminated or reduced. The recommendations in this document apply whenever a manufacturer performs human factors testing for a device.” (p. 5)

After the document is finalized, it will replace “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management” (.pdf) that was issued on July 18, 2000.

I’m looking forward to reviewing it and submitting comments.

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