MITA Urges Temporary FDA Regulatory Changes to Quickly Get Mobile Imaging to Emergency COVID-19 Pandemic Hospitals

04.01.20

Rosslyn, VA– The Medical Imaging & Technology Alliance (MITA) today sent a letter to the Food and Drug Administration (FDA) outlining key steps the agency can take to help the medical imaging industry swiftly and thoroughly aid the response to the COVID-19 pandemic. Addressed directly to the agency’s Deputy Director for Radiological Health, Dr. Robert Ochs, the letter affirms the sector’s commitment to meet the expected increase in demand for medical imaging equipment. In order to meet this demand, the industry is requesting temporary regulatory flexibility that will help manufacturers expeditiously respond more effectively to the present crisis.

“The COVID-19 pandemic poses an unprecedented health challenge. Medical imaging is playing an important role helping scientists and physicians better understand and confront COVID-19,” said Dennis Durmis, SVP – Radiology Head of Americas Region, Bayer, and Chair of the MITA Board of Directors. “Mobile imaging is a key component in responding where the crisis is most acute and imaging manufacturers are working with the FDA and other key agencies to increase the availability of medical imaging equipment where it is most needed.”

The recommended regulatory changes include:

  • Temporarily prioritize review and clearance of medical imaging devices, like mobile x-ray systems, CT scanners and portable ultrasound systems, which play a role in the COVID-19 care pathway.
  • Whenever possible, leverage Third Party Review recommendations for current imaging device submissions and expedite the issuance of accession numbers for 510(k) cleared products being imported to address the COVID-19 pandemic.
  • Given the significant and shifting expected demand, temporarily grant greater flexibility for static to mobile conversions for 510(k) cleared medical imaging systems.
  • Grant temporary flexibility for the use of alternate components and supplier qualification in order to meet increased demand.
  • Assess the full impact of facility and importation customs inspections on timely delivery of medical imaging devices and potentially postpone inspections until the COVID-19 crisis has abated.
  • Work with the Department of Homeland Security (DHS) and other agencies to meet the growing demand for medical imaging devices in severely affected areas and facilitate movement of personnel servicing these medical devices.

Importantly, none of the recommended changes would affect the safety and efficacy of medical imaging devices. Instead, implementation of the outlined recommendations would help facilitate the timely delivery of vital medical imaging equipment during a time of critical need.

“We stand ready to work with the FDA to address this public health emergency by helping to ensure healthcare providers have the medical imaging resources they need to mitigate risk and save lives,” Durmis concluded.

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