CERVICAL CYTOLOGY DEVICES USING UNCONVENTIONAL SAMPLES
This article was originally published in The Gray Sheet
Executive SummaryCERVICAL CYTOLOGY DEVICES USING UNCONVENTIONAL SAMPLES may need "longer clinical studies" to demonstrate clinical accuracy, FDA says in a July 25 draft points-to-consider document on cytology devices for gynecologic specimens. Cervical cytology devices "that are not based on conventional Pap smears" may require longer studies of clinical outcome, FDA explains, "because it may not be possible to use archival cases for longitudinal studies." FDA presented the document for discussion at the Aug. 5 meeting of FDA's Hematology and Pathology Devices Advisory Panel.
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