On March 22, 2020, the U.S. Food and Drug Administration (“FDA”) issued guidance, for immediate implementation, that aims to increase the availability of ventilators and other respiratory devices needed to address the COVID-19 pandemic. While FDA urges health care facilities to use, wherever possible, FDA-cleared standard full-featured ventilators to treat COVID-19 patients (as well as other patients requiring ventilatory support), FDA will allow a more flexible approach to modifications to these devices to help boost manufacturing capacity and supply. FDA also took the opportunity to lay out guidelines that encourage submission of Emergency Use Authorization (“EUA”) applications for devices not marketed in the United States, continuing an unprecedented Agency response to the pandemic.
Guidance Scope
Specifically, FDA will allow manufacturers of certain FDA-cleared ventilator/respiratory devices (as detailed in the table below) to make modifications to the indications, claims, functionality, or to the hardware, software, or materials of the device without making a new 510(k) submission to FDA, so long as the modification will not create undue risk in light of the public health emergency. Such changes, which would normally require a new 510(k), could include a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
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