FDA To Clarify Scope Of Devices Covered By Human Factors Guidance

26 Mar 2012

FDA is reviewing 600-plus comments on its draft human factors guidance and plans to "be much more specific" in the final version about the types of devices subject to the new data recommendations.

FDA plans to "be much more specific" about the types of devices that will be subject to human factors data expectations when it finalizes a guidance on the topic, according to a device center staffer.

Molly Follette Story, a human factors and accessible medical technology specialist in CDRH’s Office of Device Evaluation, said the agency...