Human factors evaluation in premarket submissions to be sought by FDA.
This article was originally published in The Gray Sheet
Executive Summary
HUMAN FACTORS EVALUATION IN PREMARKET SUBMISSIONS TO BE SOUGHT BY FDA as part of a plan to focus more attention on human factors associated with medical device use. Unveiling the "early stage" plan at a Sept. 12-13 conference on human factors in medical devices sponsored by FDA and the Association for the Advancement of Medical Instrumentation, Susan Alpert, director of FDA's Office of Device Evaluation, stated, "Our goal is to evaluate human factors in IDEs, 510(k)s and PMAs." The plan also would include components for good manufacturing practices inspections and postmarket activities.
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