Guidance: FDA Will Look Other Way If Manufacturers Modify Imaging Systems To Fight COVID-19

27 Apr 2020

• By Shawn M. Schmitt

The US agency has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images, as US health care workers fight the novel coronavirus.

Stationary Diagnostic Radiographic and Fluoroscopic X-ray System in hospital — Stationary X-ray systems are covered under the FDA’s immediately-in-effect guidance

Recognizing the need for more devices to assist in the diagnosis and treatment of lung disease in patients with the novel coronavirus, the US Food and Drug Administration has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images.

“Increasing the availability of mobile and portable systems may increase options to image patients inside and outside of health care...