Dear FDA panel closes out the 2016 International Symposium on Human Factors and Ergonomics in Health Care
On April 16, 2016, Adam Shames of Core Human Factors, Inc. presented on the scope of human factors regulation at FDA. Summary: It’s been almost five years since the FDA published its Draft Guidance.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: pan