The US Food and Drug Administration (FDA) on Thursday issued guidance detailing relaxed policies for imaging systems and non-invasive fetal and maternal monitoring devices to increase the availability of the devices amid the coronavirus disease (COVID-19) pandemic.
The two guidelines, which take effect immediately, follow similar guidelines released in recent weeks covering diagnostic tests, ventilators, surgical apparel, face masks and respirators.
In its enforcement policy for imaging systems, FDA says its goal is to increase the availability of X-ray, ultrasound and magnetic resonance imaging systems, as well as image analysis software, to reduce patient and healthcare provider exposure to COVID-19.
“Increasing the availability of mobile and portable systems may increase options to image patients inside and outside healthcare facilities, which could help to reduce the spread of COVID-19,” FDA writes.
Within the guidance, FDA explains that for the duration of the public health emergency, it does not intend to object to certain modifications made to imaging systems and image analysis software, including modifications to make imaging systems mobile or portable.
For image analysis software, FDA says companies can make modifications to add lung segmentation and measurement capabilities, to identify and evaluate findings related to COVID-19 and to aid in patient evaluation and monitoring using “quantitative metrics derived from patient images.”
FDA says companies that modify devices in line with the policy may do so without submitting a 510(k) or premarket approval application (PMA), so long as the device does not create an undue risk.
The guidance also lays out recommendations for validating changes made to devices, labeling, clinical decision support software and explains FDA’s policy for imaging system maintenance and servicing during the pandemic.