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Thomas Regulatory is assisting clients FDA Emergency Use Authorization Submissions due to COVID-19 Coronnavirus

04/08/2020

TRR is pleased to announce that due to the COVID-19 Pandemic due to Coronavirus, FDA has allowed for modified requirements for medical device manufacturers that wish to distribute their product during the public health emergency and pandemic. We are assisting manufacturers who can contribute to the supply of the much needed medical device products and personal protective equipment which are in shortage. There is no FDA Fee related to an Emergency Use Authorization Submission. We are happy to be assisting clients with their submissions at this time as we all work together to mitigate the effects of COVID-19.


TRR is currently scoping projects for manufacturers interested in Emergency Use Authorizations to assist with this regulatory pathway to distribution that does not require a 510(k) submission and FDA guarantees that it is reviewing all Emergency Use Authorizations in a "timely manner" so that the supply may be supported as soon as possible.


TRR provides services to support your FDA Emergency Use Authorization Submission. Reach out to us today via email at dallas@thomasregulatory.com or via text message to +1 561 898 0260 . 


Products Listed so far that may qualify for an Emergency Use Authorization are as follows which TRR can support :

  • Face Masks (Surgical and Non-Surgical)
  • Ventilators
  • Respirators
  • Anesthesia gas machines modified for use as ventilators 
  • Positive pressure breathing devices modified for use as ventilators 
  • Ventilator tubing connectors
  • Ventilator accessories 
  • Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices
  • Remote Ophthalmic Assessment and Monitoring Devices
  • Infusion Pumps and Accessories 
  • Clinical Electronic Thermometers 
  • Gowns, Other Apparel, and Gloves 
  • Sterilizers, Disinfectant Devices, and Air Purifiers 
  • Other Respiratory Devices
  • Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring
  • Digital Health Devices for Treating Psychiatric Disorders.


Again, reach out to us today via email at dallas@thomasregulatory.com or via text message to +1 561 898 0260.


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