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DEVICE SOFTWARE IMMUNITY TO YEAR 2000 DATE CHANGE SHOULD BE ADDRESSED IN PREMARKET SUBMISSIONS, FDA SAYS; ANALYSIS OF EXISTING DEVICES RECOMMENDED

This article was originally published in The Gray Sheet

Executive Summary

Device premarket submissions must address the issue of software compatibility with the year 2000 date change, FDA says in an upcoming letter to manufacturers. "For future medical device premarket submissions, manufacturers should assure that the products can perform date recording and computations that will be unaffected by the year 2000 date change," the agency says.
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