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FDA Shoots For New 510(k) Modification Draft Guidance In 2016

This article was originally published in The Gray Sheet

Executive Summary

The agency is taking another stab at clarifying its views on when a 510(k) is needed for a device modification in a draft guidance it hopes to issue next year, after having to abandon its 2011 effort in the face of stakeholder revolt. The device center's Michael Ryan previews what to expect.


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