由 John W. Mitchell
, Senior Correspondent | April 07, 2020
In response to the COVID-19 pandemic, the Medical Imaging and Technology Alliance (MITA) has asked the FDA for regulatory flexibility to get medical mobile imaging reinforcements to the front line of patient care faster.
MITA requested the changes in a letter to the FDA on April 1.
“The COVID-19 pandemic poses an unprecedented health challenge,” said Dennis Durmis, chair of the MITA board of directors. “Mobile imaging is a key component in responding … 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.”
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Among the regulatory changes MITA is advocating for:
• 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 qualifications to meet increased demand.
• Assess the full impact of facility and importation customs inspections on the 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 the movement of personnel servicing these medical devices.
MITA stressed that none of the proposed changes would put medical staff or patients at risk as safety and efficacy standards would remain in force. Instead, Durmis said, the changes would help the mobile sector deliver imaging capability faster to caregivers to mitigate risk and save lives.