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On April 16, 2016, Adam Shames of Core Human Factors, Inc. presented on the scope of human factors regulation at FDA.


It’s been almost five years since the FDA published its Draft Guidance. While the guidance has been tremendously helpful in improving the safety and effectiveness of medical devices, there are opportunities to enhance the FDA’s approach: to improve the quality and validity of the human factors data we collect and conclusions we draw from human factors studies. Five years of practice is also a sufficiently long time to begin to ask the broader question of whether the FDA should redefine the boundaries of its approach to human factors?

The panel consisted of four human factors experts. Each panelist had 12 minutes to make a case for changing some aspect of the FDA’s current thinking on human factors. The discussion was relevant to both CDRH and CDER and aimed to provide an equivalent of an open letter to the FDA. The arguments were science-based: panelists provided a solid rationale, based on human factors principles, for the recommendations. The panel also considered the merits of other proposals provided by the moderator and members of the audience.

The discussion covered the FDA’s approach to human factors for both medical devices and combination products.

In past symposia, many presentations focused on interpreting the FDA requirements, or in describing efforts to conduct human factors programs or activities aimed at meeting the FDA’s requirements. The panel is unique in it’s effort to suggest science-based modifications to the Agency’s current thinking; to provide a stimulus for enhancing how human factors efforts can better support the regulatory mission of developing safer and more effective medical products.

Learning Objectives
Several talks in the past have focused on interpreting the FDA’s current thinking, or described case studies illustrating efforts to meet the FDA’s expectations for human factors. The panel was unique in its efforts to suggest how the FDA could enhance or even redefine its human factors strategy. As a panel, it provided a forum for well known and highly regarded experts to share their views, and permitted the audience to shape the discussion through questions to panelists.