This article was originally published in The Gray Sheet
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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FDA expects to assume all duties related to the categorization of in vitro diagnostics conducted under the Clinical Laboratory Improvement Amendments from the Centers for Disease Control and Prevention by Jan. 31, 2000.
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