TriPath Imaging
This article was originally published in The Gray Sheet
Executive Summary
FDA will not approve firm's PMA supplement to allow screening of AutoCyte PREP thin-layer preparation slides on the AutoPap system until it has fully investigated assertions made by a former employee questioning the use of the AutoPap to screen thin-layer preparations, firm announces April 2. An internal investigation has determined the assertions to be false, company manitains. Supplement was originally filed in October 1999. Additional data from a prospective, masked trial was submitted to FDA in December. TriPath may accept limitations in proposed product labeling to secure faster approval of the supplement, or choose to "collect additional data to support the current labeling proposal"
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