Rosslyn, VA– The Medical Imaging & Technology Alliance (MITA) today applauded the Food and Drug Administration (FDA) for issuing guidance giving imaging manufacturers crucial flexibility in responding effectively to the COVID-19 national health emergency. The updated guidance comes after MITA issued key recommendations for the agency to adopt to empower the sector during the present crisis.

The final guidance, “Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” is effective immediately and will increase the availability of mobile and portable systems, as well as the diagnostic imaging options for patients both inside and outside of healthcare facilities–an essential step in responding to the pandemic.

“The additional flexibility by FDA for medical imaging device manufactures will enable expedient delivery of imaging products to where they are needed to meet demand in response to the COVID-19 pandemic,” said Patrick Hope, Executive Director, MITA.
Importantly, the guidance affirms the agency’s intent not to object to certain modifications of medical imaging products or their indications. Examples of circumstances where FDA currently believes modification would not create undue risk include:

Expansion of indications for use beyond the cleared/approved indications (e.g., extremity-only use expanded to other body parts) to acquire images in situations where no alternatives exist at a facility
Modifications that expand mobility, portability, or relocation of medical imaging systems (e.g., motors, batteries, electrical components, or other hardware and/or software modifications that enable conversion of fixed to mobile imaging systems; provide or increase the capability for wireless use or remote use; design changes intended to reduce electromagnetic emissions in confined spaces to prevent electromagnetic interference with surrounding systems)
Modifications to protect the operator or patient (e.g., the addition of a barrier to protect the operator or patient from scatter radiation or to provide additional protection against disease transmission)
Design modifications to improve the ability to clean, disinfect, and/or sterilize the product
Material changes to components (e.g., use of portable solid-state detectors) where the change does not significantly degrade image quality and potential hazards associated with the modifications (e.g., scatter radiation or pinch-points) are identified and mitigated by design and/or labeling

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