Patients with COVID-19 may develop respiratory illness, distress, and insufficiency and may require respiratory devices including ventilators, anesthesia gas masks, and other devices to support their treatment. However, with the number of confirmed cases in the U.S. increasing daily, there is growing concern that the supply of respiratory devices to treat patients with COVID-19 is insufficient to meet demand.
On March 22, 2020, the FDA issued guidance entitled “Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” and shortly thereafter released an Emergency Use Authorization (EUA) on March 24, 2020. The FDA hopes to ensure sufficient availability of devices for patients that need ventilatory support. In this guidance, the FDA indicates that health care facilities should use FDA-cleared ventilators (or devices subject to an Emergency Use Authorization) when necessary to support patients. However, for the duration of the declared public health emergency, the FDA does not intend to object to the following modifications without prior submission of a 510(k) premarket notification, provided that the modification will not create an undue risk, in light of the public health emergency:
This policy aims to create more flexibility for manufacturers to make device modifications to address current manufacturing limitations or supply shortages, including changes to a ventilator motor to allow an alternate supplier to meet required design specifications, or changes to the material in the ventilator tubing to allow for material sourcing alternatives. Notably, the FDA does not define what constitutes an “undue risk,” but provides several examples of modifications and use that would not create an undue risk in each category.
1. Modifications to indications, claims, or functionality: The FDA provides the following examples of modifications to indications, claims or functionality that would not create an undue risk:
2. Hardware, software, or material changes: The FDA provided the following examples of modifications to device hardware, software, and material that would not create undue risk:
Note, however, that the FDA guidance requires manufacturers to document changes to their device in their master record and change control records and manufacturers must make records available to the FDA upon request.
3. Use of ventilator beyond the indicated shelf life: The FDA guidance indicates the FDA does not object to changes in the indicated shelf life and duration of use of ventilator and anesthesia gas machine breathing circuit devices without a prior 510(k) notification where the change does not create an undue risk.
Additionally, the FDA guidance includes labeling guidelines for modified devices. Modified devices should be labeled to include:
Finally, in the EUA, the FDA authorizes the emergency use of ventilators, gas masks, and anesthesia gas machines modified for use as ventilators for treating patients during the COVID-19 pandemic. The FDA waives current good manufacturing practice requirements and certain registration and listing requirements during the duration of the EUA. The FDA indicates that it will work with manufacturers to support the wider availability of devices for patients who need ventilator support and interested sponsors can contact the FDA at CDRH-COVID19-Ventilators@fda.hhs.gov.
The FDA is implementing this guidance immediately, but remains subject to comment. For more information, please contact your Foley relationship partner or the Foley colleagues listed below. For additional web-based resources available to assist you in monitoring the spread of the coronavirus on a global basis, you may wish to visit the websites of the CDC and the World Health Organization.
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