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FDLI meeting

This article was originally published in The Gray Sheet

Executive Summary

"Medical Device Update '98" meeting is planned for June 24-25 in Washington, D.C. Among the topics to be addressed by FDAers are: accelerated approvals and reviews (Susan Alpert, director, ODE); quality system regulation (Kimberly Trautman, Good Manufacturing Practices/Quality Systems Expert, Office of Compliance); international harmonization (Larry Kessler, director, Office of Surveillance and Biometrics); postmarket requirements (Thomas Gross, director, Division of Postmarket Surveillance, OSB); and refurbishers (Casper Uldricks, special assistant to the director, OC). For more information call 1/800-956-6293...



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