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FDA Identifies Potential High-Risk Devices, Will Conduct Y2K Audits

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers not responding to FDA's most recent year 2000 survey of computer-controlled potentially high-risk medical devices (PHRDs) likely will be targeted for follow-up audits, according to Center for Devices and Radiological Health Office of Compliance Director Lillian Gill.
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