Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List
Instructor:
Robert A North
Product ID: 704551
- Duration: 90 Min
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This webinar will discuss key differences in submission requirements between the FDA draft guidance on human factors, released in 2011, and the final guidance released on February 3, 2016, entitled Applying Human Factors and Usability Engineering to Medical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 An additional discussion in this webinar will focus on the FDA’s accompanying draft guidance regarding a list of high priority medical devices requiring human factors testing and, for non-listed devices, the conditions which may dictate that human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
Dr. Robert North is a regulatory-affairs focused human factors consultant specializing in the application of methods and analysis techniques for the management and control of medical device use related hazards, and usability measurement, particularly as applied to the FDA pre-market device approval process and international usability standards compliance. He has consulted with over 100 companies regarding the implementation and documentation of medical device usability and use safety. Dr. North is currently the faculty lead of the Association for the Advancement of Medical Instrumentation’s (AAMI) three day human factors course.
More Training By Experts
- Addressing the Elusive Use Error: Meeting Regulatory Expectations for Identifying and Controlling Medical Device Use-Related Hazards
- Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?
- Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities
- Applying Human Factors Best Practices for Medical Device Risk Management
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