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Predicate Device Removal May Trigger 510(k) Rescissions - Proposed Rule

This article was originally published in The Gray Sheet

Executive Summary

FDA's Center for Devices and Radiological Health may rescind 510(k) clearance for a device if its predicate is removed from the market "for safety or effectiveness reasons" by either FDA or the product's manufacturer, the agency states in a Jan. 16 proposed rule.

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