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Human Factors and Predicate Combination Products
Jul 20, 2017 - 09:00 AM - Jul 21, 06:00 PM
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Courtyard by Marriott Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Hwy, Arlington, VA 22202,
Phone: 1 929 900 1853
The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring.
Why should you attend:
Areas Covered in the Session:
Day 1 Schedule
Overview of Human Factors and the FDA perspective
Human Factors Methods and Device Product Life Cycle
Human Factors and Risk Analysis & Management
Human Factors: What Devices Require Human Factors Evaluation and Validation?
Day 2 Schedule
Human Factors and Combination Products (Part 1)
Human Factors and Combination Products (Part 2)
Human Factors and Combination Products Submitted in an ANDA (Part 1)
Human Factors and Combination Products Submitted in an ANDA (Part 2)
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