Recognizing the need for more devices to assist in the diagnosis and treatment of lung disease in patients with the novel coronavirus, the US Food and Drug Administration has relaxed its enforcement policy for X-ray, ultrasound and magnetic resonance imaging systems, as well as software for analyzing images.
“Increasing the availability of mobile and portable systems may increase options to image patients inside and outside of health care facilities, which could help to reduce the spread of COVID-19,” the agency says in an immediately-in-effect guidance document.
“Additionally, modified use of ultrasound imaging systems may expand the number of health care practitioners capable of performing this imaging technique,” the FDA adds.
The 23 April guidance, “Enforcement Policy for Imaging Systems Used During the Coronavirus Disease (COVID-19) Public Health Emergency,” will be revoked when the national public health emergency is over.
The guidance says some imaging systems “have the potential to be modified into mobile or portable systems” so COVID-19 patients can stay away from large health care facilities to avoid passing on the disease. The document provides a detailed listing of the types of imaging devices and software covered by the guidance.
The FDA goes on to say that “some of these products that are software-based have the potential to provide radiological findings that could aid a health care professional in diagnosis of a particular condition or monitoring of disease state/severity.”
Therefore, the agency says it will look the other way if manufacturers of imaging systems and software make modifications to their already FDA-cleared or -approved products, as long as the changes don’t create an undue risk. The guidance offers roughly three pages of examples of modifications that would and would not create such risk.
The FDA stresses in its guidance that any changes made to the hardware, software, materials or duration of use of imaging systems should be validated by firms. The agency lists an array of international standards manufacturers can use to do this, including those from the International Electrotechnical Commission (IEC), the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI) and the National Electrical Manufacturers Association (NEMA).
Companies that modify their products must document the changes in device master records and change control records, the guidance says. It further notes that labeling should be included to help users “better understand the product modifications,” and offers 11 suggestions for items that could be included in labeling.
The guidance further says the FDA won’t object to:
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- Delays in actions required to repurchase, repair or replace defects of failures in electronic products that are non-life-threatening or non-serious if the firm can’t access the imaging system, is partially shut down or has problems getting parts from suppliers;
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- Delays in the reporting of Accidental Radiation Occurrence Reports;
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- A discontinuation of submissions of FDA Form-2579 – “Report of Assembly of a Diagnostic X-Ray System” – by X-ray systems assemblers, although the agency “expects reports to be submitted to the purchaser and, where applicable, to the state agency responsible for radiation protection”; and
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- A discontinuation of reports by makers of X-ray products, as required by 21 CFR Part 1002, “Records and Reports.”
The guidance also notes the agency won’t “determine whether there is an accession number during the importation of shipments of diagnostic X-ray systems.”
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