Medical Devices

Applying Human Factors and Usability Engineering to Medical Devices - February 19, 2016


On February 19, 2016, the FDA will hold a webinar for industry to review the Applying Human Factors and Usability Engineering to Medical Devices guidance document. This guidance will assist medical device developers in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environment. The 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.

We welcome your questions about this final guidance, so please mark your calendars to participate.

Webinar Details:

Registration is not necessary

Date: February 19, 2016
Time: 1:00 – 2:30 PM, Eastern Time.
To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar

To hear the presentation and ask questions:
Dial: 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:

NOTE: The FDA does not provide Continuing Education (CEU) or Certificates of Attendance for webinar attendance.

Target Audience: Industry

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at, 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health

Page Last Updated: 11/08/2016
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