A Narrative Review of FDA Human Factors Validation Requirement: The Needs of Key Stakeholders and Proposal of an Industry (Human Factors Service Providers) Maturity Assessment Tool

As part of a comprehensive Quality System Regulation (QSR), the human factors (HF) validation requirement by the Food and Drug Administration (FDA) is a relatively recent topic. Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011. The scientific literature on the topic of ‘FDA HF validation requirement’ is mostly […]

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Considering the Dynamics of FDA Human Factors Validation Requirement: Implications of Failure and Need to Ensure Project Success– A Conceptual Framework

Recognizing the role of human factors engineering (HFE) in the development of medical devices and combination products that involve devices, the Food and Drug Administration (FDA) now requires human factors (HF) validations before market approval. Manufacturers are responsible for ensuring their products are safe and effective through the application of HFE. However, key stakeholders are […]

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