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Which Tasks To Include In Human Factors Validation Testing

Failure to include critical tasks in human factors validation testing is a common cause of FDA requests for additional information following submissions , which can require re-validation and may lead to costly delays in marketing your medical device. On the other hand, including too many tasks may make the testing, analysis, and reporting unnecessarily long and expensive. Med device teams want to know, which user tasks need to be included in human factors validation and which

Jason Sterkenburg

9 hours ago8 min read

11 HF Pitfalls That Trigger FDA AI Requests And How To Avoid Them

Human factors is one of the most common reasons FDA issues additional information (AI) requests following medical device submissions. FDA (CDRH) data suggests that less than 4% of human factors submissions to FDA are accepted without requests for additional information (AI), see Figure-1 [1]. That means there are an overwhelming majority of submissions that are resulting in AI requests, often due to preventable mistakes. AI requests can lead to costly delays that affect the

Jason Sterkenburg

Jan 2111 min read