Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enforcement-policy-non-invasive-fetal-and-maternal-monitoring-devices-used-support-patient?utm_campaign=2020-04-23%20COVID-19%20Fetal%20and%20Maternal%20Monitoring%20Devices&utm_medium=email&utm_source=Eloqua

FDA Issues New Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During COVID-19

The U.S Food and Drug Administration (FDA) has issued an immediately in effect guidance to help expand the availability and capability of non-invasive fetal and maternal monitoring devices that measure or detect fetal heart rate, maternal heart rate, and/or uterine activity. These prescription devices include:  Fetal dopplers that lay users (such as patients or caregivers) could be instructed to use in a home setting under the direction of a health care provider. Fetal and maternal monitoring devices that could be used by a health care provider in a home setting.

Read the Guidance This policy reflects the FDA’s commitment to ease burdens on health care providers and facilities as they face COVID-19. Questions? If you have questions about this guidance, contact 1-888-INFO-FDA or CDRH-COVID19-FetalMonitors@fda.hhs.gov.