The guidance also outlines additional flexibility for ultrasound systems, including the following examples of circumstances where FDA currently believes a modification would not create undue risk:

Modifications to enable the use of ultrasound outside its cleared environment of use (e.g., in a temporary imaging situation with different or more variable environmental conditions, such as a general practitioner’s office or a field hospital)
Modifications to enable the collection of images by healthcare practitioners who are not trained in sonography, under the guidance or supervision of a trained or licensed healthcare practitioner (e.g., functionality to enable remote guidance)
Addition of a lung scanning clinical application (and/or lung scanning pre-sets)

Greater flexibility for the importation of certain x-ray products for the duration of the public health emergency is also granted in the guidance. This represents another noteworthy policy change that will expedite the delivery of capital medical equipment along the importation supply chain.

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