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Registration and listing reengineering

This article was originally published in The Gray Sheet

Executive Summary

Stakeholder meetings to be held in Dallas, Texas and Irvine, California on Sept. 19 and 20, respectively, will discuss FDA's proposal to require device registration and listing via the Internet, an Aug. 16 Federal Register notice announces. In addition to changes in the timelines for registration and listing (1"The Gray Sheet" May 31, 1999, p. 5), FDA is considering "streamlining the collection of [medical device reporting] baseline information" through the device listing process

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