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In Brief: MDR variances

This article was originally published in The Gray Sheet

Executive Summary

MDR variances: FDA's Office of Surveillance and Biometrics issues four variances to address difficulties relating to formatting manufacturer report numbers required on MedWatch form 3500A under the agency's medical device reporting rule. A July 16 letter sent to device firms says the variances apply to situations in which: "several reporting sites share the same registration number and also share the number with a manufacturing site at the same location that makes devices for the reporting sites"; "reporting sites have different registration numbers but share the same manufacturing site"; "multiple manufacturing sites at the same location share the same registration number"; and "a device is manufactured at more than one site." For the first three cases, companies can request that FDA issue an "assigned reporting number" in order to alleviate any report number confusion; in the remaining cases, if firms are unable to determine which manufacturing site produced a device involved in an adverse event, the company "may arbitrarily assign a manufacturing site using any method of assignment." For further information, contact OSB's Reporting Systems Monitoring Team at 301/594-2735...

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