FDA Encourages Human Factors Testing for Medical Devices and Combination Products

Thursday, February 11, 2016

Source: AAMI

The Food and Drug Administration (FDA) has released new recommendations for human factors testing of medical devices—two drafts and one final document—emphasizing the importance it has placed on improving the usability of medical technology.

The final guidance document—Applying Human Factors and Usability Engineering to Medical Devices—is “intended to support manufacturers in improving the design of devices to minimize potential use errors and resulting harm,” according to the FDA. To that end, the guidance provides descriptions of the human factors and usability engineering processes that can be employed by manufacturers during device development.

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