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US FDA Renews Effort To Demystify 510(k) Device Modification Policy

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration is taking another stab at clarifying its views on when a pre-market notification, or 510(k), application is needed for a medical device modification in a draft guidance it hopes to issue next year, after having to abandon its 2011 effort in the face of stakeholder revolt1,2.

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