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FDA Issues Policy Regarding All Digital Imaging Diagnosticss During Health Crisis

Apr 27, 2020


The Food and Drug Administration has issued a policy regarding all Diagnostics imaging during the public health emergency. This emergency policy has been input to counter the drastic changes to social distancing in recent weeks. Unfortunately, this pandemic cannot cease pains and afflictions that require people to need digital imaging done. In order to provide safer and aid and a guideline for medical officials and patients who need digital imaging, this policy has been placed into effect as of April 26, 2020.

What Are the Guidelines?

First of all, if you wish to read the entire issued policy, the link to the document is right here. They intend to increase the readiness of all digital imaging technology immediately. Also, modifications are being input on these devices that will enable them to detect pulmonary abnormalities with ease. All of these modified devices will be labeled and validated upon completion. Many digital imaging locations will be mobile or be using portable systems that can aid if trying to test for COVID-19 implications. All in all, they are trying to enable the use of these digital imaging devices on a widespread scale. Quickly, efficiently and safely.

Notes from the Policy

“FDA believes that it is important to help facilitate availability of the devices listed above and to help leverage the use of current mobile and portable radiological products, which may help ease the burden on hospitals, other healthcare facilities, and healthcare professionals that are experiencing increased demand due to the COVID-19 pandemic.”

“In developing this policy, FDA’s intent is to foster the continued availability of safe and effective medical products while being flexible regarding modifications made to imaging systems that are used to diagnose and/or monitor medical conditions during the COVID-19 public health emergency.”

“Software, including mobile apps, may be useful in connection with imaging patients with COVID-19 or co-existing conditions and providing clinical decision support.”