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Human Factors Studies Are Part of the Regulatory Framework

If you don't integrate human factors engineering into your design control, you may face eventual consequences from FDA, regardless of your product's classification, said Pat Patterson of Agilis Consulting (Cave Creek, AZ) last night. She spoke at a meeting of the RAPS New York/New Jersey chapter. Regulatory affairs folks should be aware that PMA applications need to include data on whatever usability tests and other human factors studies were performed, and that failure to include them will raise a red flag, she said.

Such data is usually not necessary for 510(k) applications, but if a 510(k) product has a significant use-related problem, FDA will ask to see human factors testing data, she added. And if such testing was never done, a firm could get in serious trouble with the agency. "FDA wants you to show what you did in terms of figuring out what predictable things could go wrong," she said. "`Nothing' is the wrong answer." Clinical trial data is not a substitute for human factors data, nor is a standard Failure Mode and Effects Analysis, nor especially is a labeling comprehension review, she stressed.

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