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A New NEST: MDIC Leaders Discuss Relocation, National Evaluation System And More

Executive Summary

Medical Device Innovation Consortium's CEO William Murray and VP for Technology Innovation Dawn Bardot sat down with Medtech Insight during the recent Design of Medical Devices conference in Minneapolis to discuss what their organization has been doing lately and some future focuses in the areas of regulatory science and device data collection.

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The National Evaluation System for health Technology, which FDA officials have said will re-make device data collection in the US, is finally getting off the ground. Rachael Fleurence took the helm last month as the executive director for the NEST Coordinating Center. In a podcast interview with Medtech Insight, Fleurence talks about her qualifications, and what she hopes the project will accomplish within the next year, and beyond.

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US FDA's device-center head discussed his continued push to make regulations more flexible, plans for least-burdensome training and what's next for NEST, among other topics, at the Food & Drug Law Institute annual gathering in Washington DC.

Pilot Of New US Evaluation System Will Include At Least Two Devices

New details about the planned pilot launch of the National Evaluation System for health Technology were included in US FDA's recently posted user-fee reauthorization commitment letter. At least one PMA and one 510(k) product type must be piloted on the real-world evidence system. Device center director Jeff Shuren continued to tout the program at this year's AdvaMed conference.

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