The FDA, which plays a critical role in protecting the US from threats such as emerging infectious diseases, including COVID-19, has issued the Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The policy aims to help expand the availability and capability of medical x-ray, ultrasound, and MRI systems, and image analysis software 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.
The policy will span the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, and renewed for 90 days on April 21, 2020, effective April 26, 2020.
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)).
Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled "Process for Making Available Guidance Documents Related to Coronavirus Disease 2019," this guidance is being implemented without prior public comment. That’s because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)).
This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.Back To Top
FDA issues imaging system enforcement policy during COVID-19. Appl Rad Oncol.