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Expert Analysis

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 new products that can be found substantially equivalent to existing, marketed predicate devices....

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