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Expert Analysis

Concerns For 510(k) Sponsors After FDA Proposes Major Shift

By Kristin Davenport, Christina Kuhn and Amy Leiser (September 18, 2023, 10:08 AM EDT) -- For several years, the U.S. Food and Drug Administration's Center for Devices and Radiological Health has been vocal about its views regarding the limitations of the 510(k) pathway and the need for modernization to keep up with advances in technology. In 2018, the CDRH proposed an approach that would sunset older predicates and promote the use of more modern predicates.[1]...

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