FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. This system has proven effective at initially identifying samples that show signs of possible abnormal cell growth.
Early detection is crucial in successfully treating the disease.
FDA approved the product after evaluating data from a multi-center clinical study involving the analysis of more than 31,500 Pap smear slides. This device is approved for use by individuals trained in Pap smear testing and is to be used only on conventionally prepared Pap smear samples. Pap smear samples that are identified as potentially problematic by this automated system's initial screening will be re-evaluated by human analysis.