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Chart: More 510(k) Reform Fears: Condition of Clearance Studies, GMPs?

This article was originally published in The Gray Sheet

Executive Summary

FDA is weighing other changes to the 510(k) program, as well, such as requiring "condition of clearance" studies for 510(k) devices, a common practice for PMA approvals, or incorporating information from manufacturing inspections into 510(k) reviews.

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