Recent Organizational Change Reflects Increased Human Factors Emphasis

The FDA's Human Factors group has moved within the FDA organization to the Office of Device Evaluation futher underscoring the importance of human factors in the regulatory process of reviewing PMAs, 510(k)s and other manufacturer submissions.

Human Centered Strategies looks forward to discussing how use error may be identified and controlled in the design of your medical device. Often, this may include facilitation of dicsussions with the FDA's Human Factors Team to identify the optimal use error risk management strategy for your situation.

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