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GMP design controls should be phased in over 18 months -- FDA panel.

This article was originally published in The Gray Sheet

Executive Summary

DEVICE COMPONENT MANUFACTURER EXCLUSION FROM REVISED GMPs unanimously endorsed by FDA's Device Good Manufacturing Practices Advisory Committee Sept. 14 at a meeting in Gaithersburg, Maryland. The panel's recommendation was in line with FDA's latest position that GMPs should not be applied to component manufacturers; the agency had taken the opposite stance in a "working draft" of a final rule on GMP revisions released in July ("The Gray Sheet" July 24, p. 4).
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