FDA has released the final guidance document 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.

According to the document, “Modified use of these devices may increase access to important prenatal data without the need for in-clinic visits and facilitate patient management by health care providers while reducing the need for in-office or in-hospital services during the COVID-19 public health emergency. Increased utilization of non-invasive fetal and maternal monitoring devices may ease burdens on hospitals and other healthcare facilities and reduce the risk of exposure for patients and health care providers to SARS-CoV-2.”

This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services.

Download the document and read more from FDA.