Helping to continue the fight against COVID-19

A medical professional in protective gear takes a blood sample from a patient wearing a medical mask.

From EUA to FDA Clearance: Expert support for your transition

May 11, 2023 marked the official end of the COVID-19 national public health emergency (PHE). Although the emergency use authorization (EUA) declaration is distinct from the PHE and the EUA may remain in effect, FDA guidance recommends manufacturers begin working on a marketing submission, including a transition implementation plan. 

This transition from EUA to FDA clearance is required for manufacturers to keep their products on market and the complexities can leave organizations with many questions. Beaufort’s team of experts can provide regulatory support and clinical study solutions for a successful 510(k), de novo or dual 510(k)/CLIA waiver pre-market submission.

Whether for OTC, POC, or laboratory use, we have supported sponsors throughout the pandemic with their COVID-19 diagnostic test emergency use authorizations. We are now helping clients’ draft submissions and execute clinical studies to expedite their FDA clearance. Beaufort is proud to be partnering actively with industry leaders as they continue to accelerate their medical innovations in the detection of the SARS-CoV-2 virus and in the prevention and treatment of COVID-19.

Several SARS-CoV-2 viruses are suspended against a light blue background.

COVID-19 Services and Solutions:

  • Clinical trial management
  • Protocol development
  • Study monitoring
  • Sample acquisition and management
  • Data management
  • Statistical consulting
  • Q submission /Pre-submission preparation and review
  • Marketing submission preparation and review (US 510(k) and de novo submissions, EU IVDR Technical Documentation)
  • Transition plan development


Partnering with today’s innovators

Beaufort was proud to support Moderna, Inc., a leading biotechnology company, with Clinical Monitoring Oversight services for their SPIKEVAX COVID-19 vaccine trials. These quality services were instrumental in Moderna achieving FDA approval for the groundbreaking vaccine. Our assessors continue to perform hundreds of visits at well over 200 clinical trial sites in the U.S. in support of Moderna’s COVID-19 vaccine innovations for use in both pediatric and adult populations.