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Agency outlines modifications that will and won’t be accepted without approval during the outbreak.
Providers are relying heavily on imaging services during the COVID-19 pandemic. To make it easier for some devices to be used in caring for patients infected with the virus, the U.S. Food & Drug Administration (FDA) announced is it easing its rules on any modifications made to radiology equipment. For now, manufacturers do not need to seek agency approval before implementing these changes for patient care.
In an effort to make imaging services as readily available as possible for providers treating this patient population, many practices or facilities have already changed how they’re using devices. In the April 23 statement, the FDA acknowledged that modifications to make systems mobile or portable are already occurring and said it would not step in to impede the availability of equipment for use with this patient group.
Specifically, the agency said, it did not intend to object to modifications to systems it has already cleared or approved even in situations where it would normally require a 510(k) or premarket approval application.
“In developing this policy, FDA’s intent is to help expand the availability of imaging products, including mobile and portable diagnostic imaging systems, in the United States for the duration of the public health emergency while being flexible regarding the maintenance of devices,” the agency wrote. “Wherever possible, healthcare facilities should use FDA-cleared or approved medical imaging systems and maintain this system following the manufacturer’s or other recommended maintenance schedule.”
Modifications That Won’t Pose Risks
There are modifications to imaging equipment that the FDA believed would not cause undue risk to patients:
Modifications That Are Discouraged
But, not all modifications will be accepted, the agency cautioned, because they could potentially cause undue risk.
As the outbreak has continued, the value of imaging COVID-19-positive patients with ultrasound has become clearer. And, because the modality doesn’t emit ionizing radiation, the FDA allowed for additional flexibility with modifications to ultrasound under certain circumstances.
These ultrasound modifications should be avoided:
Under some circumstances, the FDA said it would allow modifications to image analysis software:
However, these changes should be avoided because they increase risk to patients:
Although the FDA has relaxed its rules surrounding modifications for the time being, the agency did strongly recommend that manufacturers document any changes made to their products. Products must also include labeling so customers can clearly understand any modifications that have been made.