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Will the Tesla ventilator receive FDA Emergency Use Authorization by 2020-05-15?
On 2020-04-01 Tesla showcased what appears to be a working ventilator prototype. However, as of 2020-04-06 there has been no statement of when the ventilator will be ready for production.
Prior to use in a hospital, the ventilator will need to receive FDA approval. On 2020-03-24, the FDA issued an Emergency Use Authorization (EUA) for various ventilators. Additional ventilators may approved for use if they are added to Appendix B of the EUA. To be added:
...ventilators, ventilator tubing connectors, and ventilator accessories must be determined to meet the applicable criteria for safety, performance and labeling set forth in Appendix A. FDA will add a ventilator, ventilator tubing connector, or ventilator accessory to the list of authorized products in Appendix B upon submission of a request from the sponsor as described below and after confirmation that the safety, performance and labeling criteria have been met, and pursuant to the Conditions of Authorization in this EUA.
This question asks: Will the Tesla ventilator receive Emergency Use Authorization by 2020-05-15?
This question resolves positively if the Tesla ventilator is added to the existing EUA for ventilators or if it is approved for use under another EUA.
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