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Do-Over? FDA Orders Look-Back At Knee Device 510(k) Review Process

This article was originally published in The Gray Sheet

Executive Summary

In a sign of the intense scrutiny CDRH is facing under the new administration, FDA is taking the rare step of performing an internal review of its decision process for a recently 510(k)-cleared device. The inquiry could potentially lead to a "reconsideration" of the clearance, the agency says

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