Please note that the A-VS design, and devices built in accordance with the A-VS design, have not yet been approved by the US Food & Drug Administration (FDA). LifeMech is applying to the FDA for an Emergency Use Authorization (EUA) during the COVID-19 crisis for ventilators built from the A-VS design. The March 2020 FDA Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) (“Emergency Guidance”) encourages manufacturers who have not previously been engaged in medical device manufacturing, but have capability to increase supply of ventilator devices, to work collaboratively with the FDA through its Emergency Use Authorization Process (EUA).
THE A-VS DESIGN AND INFORMATION IS PROVIDED “AS-IS, WHERE-IS,” WITHOUT REPRESENTATIONS, CONDITIONS, OR WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE A-VS DESIGN AND INFORMATION WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. THE RECIPIENT IS SOLELY RESPONSIBLE FOR DETERMINING THE APPROPRIATENESS OF USING, REPLICATING, OR REDISTRIBUTING THE A-VS OPEN SOURCE VENTILATOR DESIGN AND INFORMATION. THE RECIPIENT ASSUMES ALL LIABILITY FOR DAMAGES, OF WHATEVER NATURE AND DESCRIPTION, WHETHER IN CONTRACT OR IN TORT, WHICH MAY ARISE FROM THE USE OF THE A-VS DESIGN AND INFORMATION. NEITHER LIFEMECH NOR ITS VOLUNTEERS WILL BE LIABLE TO THE RECIPIENT OR TO ANY THIRD PARTY FOR ANY LOSS, CLAIM, OR DEMAND MADE BY THE RECIPIENT, OR ANY LOSS, CLAIM, DEMAND, OR JUDGMENT AGAINST THE RECIPIENT BY ANY OTHER PARTY, DUE TO OR ARISING FROM THE USE OF THE A-VS DESIGN AND INFORMATION BY THE RECIPIENT.
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