MITA urges FDA flexibility for COVID-19 imaging

By staff writers

April 2, 2020 -- The Medical Imaging and Technology Alliance (MITA) has sent a letter to the U.S. Food and Drug Administration (FDA) recommending loosening restrictions on mobile imaging equipment to help combat COVID-19.

"Mobile imaging is a key component in responding to 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," said Dennis Durmis, chair of the MITA's board of directors and senior vice president and head of radiology of the Americas Region for Bayer HealthCare, in a statement.

The MITA is asking the FDA to take the following steps:

  • Temporarily prioritize review and clearance of medical imaging devices, such as mobile x-ray systems, CT scanners, and portable ultrasound systems.
  • Expedite third-party review recommendations for current imaging device submissions and the issuance of accession numbers for 510(k)-cleared products being imported to address the COVID-19 pandemic.
  • 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.
  • Work with the U.S. Department of Homeland Security 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.

MITA added that its recommendations would not adversely affect the safety and efficacy of medical imaging devices and would help in the timely delivery of medical imaging equipment during the COVID-19 pandemic.

Copyright © 2020

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