Sponsors often ask us, “Can we do a threshold analysis instead of submitting human factors validation data to the agency?” The short answer is: It depends! Sponsors hope for this outcome, but findings from a threshold analysis may or may not support this conclusion.
Agilis is your trusted human factors partner for the global medical market. We help new and established companies achieve successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. Agilis’ proven human factors strategies, process and expertise drive regulatory success and speed to market – the first time.