The Least Burdensome Provisions: Concept and Principles Final Guidance

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Owner: FDA (U.S. Food & Drug Administration)

2019/03/14 13:00:00 | Long > 60 min | English | (GMT-4:00) Eastern Time (US and Canada)

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From March 14, 2019.  Webinar presenting the FDA's final guidance on their use of the "least burdensome" approach to medical device regulation. The goal of this approach is to remove or reduce unnecessary burdens that might delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval.  The FDA seeks to support timely patient access to high quality, safe, and effective medical devices.  This webinar describes the guiding principles and recommended approach for consistent application of least-burdensome principles to the regulation of medical devices.

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Irene Aihie

Message Presenter

Irene Aihie is a Public Health Advisor in the FDA's Office of Communication and Education.

Joshua Silverstein

Joshua Silverstein is a Regulatory Adviser in the Office of Device Evaluation.

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