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DEVICE GMP DESIGN CONTROLS GUIDANCE WILL BE DEVELOPED

This article was originally published in The Gray Sheet

Executive Summary

DEVICE GMP DESIGN CONTROLS GUIDANCE WILL BE DEVELOPED, Fred Hooten, acting director of the Division of Enforcement III in the device center's Office of Compliance, told attendees of a Jan. 19 Health Industry Manufacturers Association seminar on the proposed good manufacturing regulation in Washington, D.C. "We're proposing developing some guidance, especially in the design area," he said.

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