Emergency Use Authorizations (EUAs)

Accelerated market access for COVID-19 related devices

On 4 February 2020, the Secretary of the Department of Health and Human Services (HHS) announced their determination of a significant potential for a public health emergency that would impact the health and security of citizens due to the COVID-19 pandemic. The HHS PREP Act declaration: Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 was published to provide liability immunity for activities related to medical countermeasures against COVID-19.

Critical times call for urgent response. In response to these activities, we understand the importance and the need to accelerate market access, specifically for COVID-19 related devices. We are closely monitoring and carefully evaluating Emergency Use Authorizations (EUAs) as they are issued by FDA, and are fully prepared to assist you in using these expedited regulatory pathways for devices that are most critical to combating this disease. We can also assist you in preparing and submitting requests for new EUAs.  As this situation is rapidly expanding globally and resources are in high demand, we are fully functioning and ready to assist you.

Our team has established relationships with the agency and the expertise to help accelerate your market approval during this unique time. We can help you navigate the complexities of this process and put our experience to work to act quickly. Contact us today to discuss your needs and what challenges you are facing.