FDA is planning a key webinar for industry to review the Applying Human Factors and Usability Engineering to Medical Devices guidance document to be held on February 19, 2016. The guidance aims to assist medical device developers in following appropriate human factors and usability engineering processes to maximize the safety and effectiveness of new medical devices for the intended users, uses and use environment. FDA recommends that manufacturers include human factors data in their premarket submissions (i.e., PMA, 510(k)) if an analysis of risk for the device indicates that users performing tasks incorrectly or failing to perform tasks could result in serious harm. Registration to the event is not necessary.
Date: February 19, 2016
Time: 1:00 – 2:30 PM, Eastern Time.
Dial in: 800-857-9761; passcode: 1636743 | International callers dial: 1-517-308-9340
To view the slide presentation during the webinar:
Following the conference, a transcript, audio recording and slides will be available at: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm