Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency | FDA

FDA Issues New Policy for Imaging Systems During COVID-19

The U.S Food and Drug Administration (FDA) has issued an immediately in effect guidance to help increase availability and capability of imaging products needed for diagnosis and treatment monitoring of lung disease in patients with COVID-19. These imaging products include medical x-ray, ultrasound and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions.  Increasing the availability of mobile and portable imaging systems may increase options to image patients inside and outside of healthcare facilities, which could help to reduce the spread of COVID-19.

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, send email to RadHealth@fda.hhs.gov.