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FDA MEDICAL DEVICE 510(K) MODIFICATIONS POLICY DRAFT

This article was originally published in The Gray Sheet

Executive Summary

FDA MEDICAL DEVICE 510(K) MODIFICATIONS POLICY DRAFT is slated for release on April 8, FDA Center for Devices and Radiological Health Director Bruce Burlington said at a March 22 session of the Health Industry Manufacturers Association annual meeting. The long-awaited draft will outline FDA's plan for guidance on submitting 510(k)s for modifications to devices that have been previously cleared for marketing by the agency.
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