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Y2K MDR exemptions

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers may file a "Y2K Exemption" notification to FDA for Year 2000-related malfunctions that are reportable under the medical device reporting requirements if the malfunctions do not result in a remedial action. However, the exemption notice must be filed with, or after submission of, one or more 30-day initial MDR reports on a Y2K-related event, FDA says in a document posted on its website Aug. 9. The "MDR Exemption Document" explains additional conditions firms must follow in order to employ the exemption process
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