FDA guidance on in vivo cervical cancer detectors suggests 100-patient feasibility study.
This article was originally published in The Gray Sheet
IN VIVO CERVICAL CANCER DETECTION DEVICES: FEASIBILITY STUDIES should include 100 patients who have had positive Pap smear results, FDA says in a June 14 draft guidance on investigational device exemptions for the products. The feasibility study should include "100 patients who have previously been found to be Pap" positive, and include at least 25 patients from each of three Pap smear diagnostic categories. Comments on the draft guidance are due by Sept. 14.
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