FDA Proposals Clarify Rules For Devices With Predicates

By Lina Kontos, Kristin Zielinski Duggan and Kelliann Payne · October 24, 2023, 6:20 PM EDT

Last month, the U.S. Food and Drug Administration Center for Devices and Radiological Health issued three new draft guidances as part of an effort to modernize its Section 510(k) program for...

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