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Center for Devices and Radiological Health

FDA releases MDUFA V details after industry negotiations

March 22, 2022 By Jim Hammerand

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA). If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after […]

Filed Under: 510(k), Blog, Featured, Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: AdvaMed, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, FDA

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May 13, 2022
Our Pre-Post-DeviceTalks Boston episode, also MedtronicTalks replay with Gastro CMO Austin Chiang
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