Even though Humanitarian Device Exemption (HDEs) and Humanitarian Use Device approvals (HUDs) have been around for many years, due to the few number of device indications that are actually designated as an HDE and subsequently receive HUD approval, most research professionals have little to no knowledge of the differences between the two terms or understand how they are operationalized in a real world setting.
In this session, Lee Truax-Bellows will provide you with a working knowledge of what each term means and a basic understanding of Sponsor, Investigator and IRB responsibilities for managing a device that has received FDA HUD approval.
Confusion on what an HDE designation and HUD approval means and how it impacts Sponsors, Investigators and IRBs is prevalent throughout the research community. This session will assist the participant in identifying and defining the two terms. Lee will discuss the responsibilities of each of the three parties that manage HUD, i.e., the Sponsor, IRBs and Site Investigators. A lecture format provided through a PowerPoint presentation will be used to educate the participant. A discussion of the final FDA Guidance titled “Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators”, and both the current and newly revised draft version of “FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers” will be included as part of the presentation.
In this 60 minute session, Lee will discuss:
At the end of this webinar participants will be able to:
Who should attend
Lee Truax-Bellows is a founder, President and CEO of Norwich Clinical Research Associates Ltd. (NCRA). NCRA is a full service clinical contract research organization (CRO) based in upstate NY.
Lee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a Monitor, Medical Communications Associate, Project Manager, Senior Quality Auditor, Senior Trainer, and Regulatory... More Info
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