FDA has issued final guidance document Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.
FDA is issuing this guidance to provide a policy to help expand the availability and capability of medical x-ray, ultrasound, and magnetic resonance imaging systems, and image analysis software that are used to diagnose and monitor medical conditions while mitigating circumstances that could lead to patient, healthcare provider, and healthcare technology management (HTM) exposure to COVID-19 for the duration of the public health emergency declared by the Secretary of Health and Human Services.
FDA believes the policy set forth in this guidance will address urgent public health concerns by helping to increase availability and capability of imaging products needed for diagnosis and treatment monitoring of lung disease in patients with COVID-19. Imaging devices can help visualize pulmonary abnormalities and are used routinely to diagnose and evaluate the causes of reduced lung function. Accordingly, there is increased demand for imaging devices that may assist in the diagnosis and treatment monitoring of lung disease.
This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Services Act (42 U.S.C. 247d(a)(2)).
Featured image: The chest X-rays of one coronavirus victim, a 44-year-old man who worked at the Wuhan seafood market.