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CDRH Y2K Website Needs Better Publicity Prior To Third-Party Audits - GAO

This article was originally published in The Gray Sheet

Executive Summary

FDA needs a coordinated publicity campaign to familiarize manufacturers and hospitals with its Biomedical Equipment Clearinghouse website addressing year 2000 compliance prior to phasing in validation/verification audits of high-risk device firms on June 1, according to the General Accounting Office.

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