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IMPLANTABLE DEVICE MANUFACTURING MODIFICATION 510(K) RULES WILL BE RELAXED UNDER REVISED FDA GUIDANCE ON 510(K)s FOR DEVICE CHANGES, PHILLIPS SAYS

This article was originally published in The Gray Sheet

Executive Summary

Implantable device manufacturing changes will require 510(k) clearance only in certain situations under revisions to FDA's 510(k) guidance document on device modifications, Philip Phillips, acting deputy director of the agency's Office of Device Evaluation, announced May 12 at an FDA/industry video conference.
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