This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.
Why Should You Attend:
This webinar will discuss key differences in submission requirements between the FDA draft guidance on human factors, released in 2011, and the final guidance released on February 3, 2016, entitled Applying Human Factors and Usability Engineering to Medical Devices. An additional discussion in this webinar will focus on the FDA’s accompanying draft guidance regarding a list of high priority medical devices requiring human factors testing and, for non-listed devices, the conditions which may dictate that human factors data may be necessary for approval.Areas Covered in the Webinar:
- Understand the intent of the final guidance regarding pre-market human factors work expected by reviewers at CDRH
- Know the key differences between the draft human factors guidance and the final guidance release
- Understand the implications of the “priority device list” and requirements regarding human factors in pre-market submissions for devices not listed
Who Will Benefit:
- Regulatory Affairs
- Product Development Managers
- Human Factors Engineers
- Quality Engineering
- Risk Management Teams
Course Provider
Robert A North,
