The US Food and Drug Administration has established emergency market access pathways known as Emergency Use Authorizations (EUA) to help maintain reliable supplies of medical devices and equipment needed during the ongoing COVID-19 public health crisis. These pathways are only temporary authorizations that are subject to removal at the FDA’s discretion.
Under the FDA’s EUA program, manufacturers have been able to produce and distribute respiratory devices using the relevant published Emergency Use Design Guidance and Disclosure Guidance for Ventilator, Resuscitator Systems and CPAP/BiPAP devices. These guidance documents minimize the overall testing protocol and will not enable continued sale of the device post pandemic EUA.
In this webinar, UL will present information concerning gaps between EUA and full compliance with published standards in order to assist the device manufacturers in maintaining products on the market after the current pandemic is over.
After the presentation, there will be time for Q&A.
Speakers will include Pamela Gwynn, Principle Engineer for UL Healthcare and Ben Dahlen, P.E., Engineering Manager for UL Healthcare