CAD Fetal Monitor PMA Trial Design Is Focus Of October Ob/Gyn Panel
This article was originally published in The Gray Sheet
Executive Summary
FDA's Obstetrics & Gynecology Devices Panel will convene Oct. 25 to discuss pivotal study design requirements for fetal monitors that use computer-aided detection for risk assessment
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FDA is determining whether general guidance should be developed for the devices, after canceling the Oct. 25 Obstetrics & Gynecology Devices Panel meeting, according to CDRH staff. The panel was slated to discuss the necessary evidence to support approval of fetal monitors that use computer-aided detection for risk assessment (1"The Gray Sheet" Sept. 27, 2004, p. 5). If FDA decides guidance is needed, it will seek input from interested parties and likely will convene the panel at that time, staffers note...
CAD fetal monitor panel nixed
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