ComplianceOnline

Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

Instructor: Robert A North
Product ID: 704551
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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This webinar will discuss key differences in submission requirements between the FDA draft guidance on human factors, released in 2011, and the final guidance released on February 3, 2016, entitled Applying Human Factors and Usability Engineering to Medical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 An additional discussion in this webinar will focus on the FDA’s accompanying draft guidance regarding a list of high priority medical devices requiring human factors testing and, for non-listed devices, the conditions which may dictate that human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

Instructor Profile:

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.

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