In Brief: Obstetrics and Gynecology Devices Panel
This article was originally published in The Gray Sheet
Executive Summary
Obstetrics and Gynecology Devices Panel: Slated to discuss two draft guidance documents at a July 14-15 meeting in Rockville, Maryland. On July 14 the panel will discuss a draft guidance document on the study and evaluation of intrapartum continuous monitors for fetal pulse oximeters and fetal tissue pH. On July 15 the panel is scheduled to discuss a draft guidance document on the study and evaluation of in vivo devices for the detection of cervical cancer. For further information, contact FDA's Elisa Harvey at 301/594-1180...