Dr. Hankins questioned how such a requirement could be enforced and said that training is ultimately “under local purview.” When asked about enforcement, the FDA's Mr. Pollard acknowledged the validity of the question and said that the agency's authority “does not extend beyond the labeling.”
The STAN S31 system is indicated for use in patients with planned vaginal delivery, greater than 36 weeks of gestation, a singleton fetus, vertex presentation, and ruptured amniotic membranes. Simon Grant, CEO of Neoventa, the monitor's Swedish manufacturer, said the company intends to partner with a U.S. company to introduce the device to the U.S. market this year.