How Often, and Why, Will the FDA Reject your Medical Device Human Factors Submission?

The Food and Drug Administration (FDA) requires the application of human factors (HF) in the development of medical devices and combination products. The previous is checked through proper validation testing. The purpose of the HF validation is to demonstrate whether a device can be used by its intended users without any serious errors or hazards, […]

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Understanding Practices and Critical Success Factors of FDA Human Factors Validation Projects – Preliminary Findings

The quality and success of human factors validation projects have put a strain on key stakeholders since the FDA published guidance. Learn about a new study on the characteristics, practices, and critical success factors in this field. Findings are presented to inform an industry-focused project management maturity assessment tool.

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Developing an Industry-Focused Maturity Assessment Tool Based on Key Factors Critical to Quality and Success in FDA Human Factors Validation Projects – Overview

This work is Phase II of a research theme on the topic of human factors validation projects for medical devices and combination products. Initially, a review and analysis of the persisting concerns and also of the implications of failed FDA HF validation projects took place. One main problem delineated was that key stakeholders (namely procurers and […]

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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 Multiple issues and bottlenecks have emerged since the publication of the draft guidance in 2011.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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