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...

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