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CLIA transfer

This article was originally published in The Gray Sheet

Executive Summary

FDA intends to provide guidance on how requests for categorizations under the Clinical Laboratory Improvement Amendments of 1988 will be "administratively processed," the agency says in an Aug. 23 letter to in vitro diagnostic makers. The guidance will be made available prior to Jan. 31, 2000, the time at which the agency will begin handling the categorization duties currently conducted by the Centers for Disease Control and Prevention (1"The Gray Sheet" April 19, p. 3). A website also will be created to assist manufacturers with the transfer, FDA says

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