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  6. Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA’s Response
  1. Coronavirus (COVID-19) and Medical Devices

Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDA’s Response

 

At the U.S. Food and Drug Administration, much of the focus in 2020 and 2021 has been dominated by the Agency’s response to the COVID-19 pandemic. The Center for Devices and Radiological Health (CDRH) has significantly contributed to the COVID-19 response, including working to help grant emergency use authorizations (EUAs) for over 600 medical devices – more than a ten-fold increase over the number authorized in all prior public health emergencies (PHEs) combined – and authorized over 900 additional medical devices through traditional pathways, for a total of more than 1,700 medical devices authorized. 

“The FDA agrees with the priority recommendations identified by Booz Allen Hamilton in their independent assessment of our COVID-19 response. From the beginning of the pandemic, we have adapted our regulatory approach to address the public’s testing needs and worked actively with COVID-19 test developers to adjust our policies as those needs have changed or the science has evolved. We will continue to take a flexible approach to COVID-19 tests to meet public health needs and increase access to testing for consumers, including at-home diagnostic tests, which remain a top priority for the agency, that is grounded in sound science.” Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health 

As of October  8, 2021, the FDA authorized approximately 400 COVID-19 tests and sample collection devices and over 600 revisions to such EUAs. 

Emergency Use Authorization Assessment - Final Report

Read the Report (PDF - 7MB)

In March 2021, Booz Allen Hamilton was selected by the FDA to conduct an independent assessment of the FDA’s Coronavirus Disease 2019 (COVID-19) Emergency Use Authorization (EUA) response. Booz Allen Hamilton reviewed primary documents and conducted internal and external stakeholder interviews to evaluate the FDA’s response and develop recommendations for improvement. 

CDRH is sharing Booz Allen Hamilton’s independent assessment report with the public. This page highlights the recommendations from the report, along with CDRH’s perspectives and steps the Center has taken, or plans to take, to address the feedback.  

Priority Recommendations to Support the EUA Process 

The key observations, potential recommendations, and intended impacts listed below are excerpted from Table 4-2, Priority Recommendations Identified by Booz Allen Hamilton (BAH) to Support the EUA Process, in the assessment report. 

KEY OBSERVATION: Precise tracking of new review metrics was encumbered by the IT system, which is not optimized to account for updated EUA processes.  

BAH Priority 
Recommendation 
and Intended Impact		 Consider ways to optimize the IT system to account for EUA processes 
“Fully automate submission and tracking of EUA requests (e.g., linking Pre-EUA to EUA; lags while awaiting additional information from requestors; lags due to backlog or priority designation) to provide more comprehensive picture of review time from EUA submission to decision for review efficiency, performance monitoring, prioritization, process improvements, and workload management” 
CDRH Perspective 
and Next Steps

CDRH agrees with the recommendation to align IT with EUA process updates, as this will help improve tracking of EUA requests and related performance metrics.  

From March 2020 to present, CDRH took several steps to identify IT system needs to improve EUA request submission tracking. In parallel, CDRH has been working to streamline EUA processes.  

Further, CDRH initiated a Digital Transformation Initiative in Fiscal Year (FY) 2016, which is ongoing. This initiative is focused on providing better IT infrastructures, technology solutions, and data to help both internal and external stakeholders across all regulatory programs. The goal is to improve transparency, reduce duplicative efforts, create an integrated environment, and help ensure that data is organized, curated properly, and accurate for decision making. This effort will help CDRH better track future EUA requests as well as provide better platforms for interacting with medical device sponsors when questions arise about their submissions. 

KEY OBSERVATION: The approach to staff allocation was difficult to systematically quantify and analyze, making it difficult to determine what events or criteria triggered shifts in staff and how shifts were coordinated to address the triggering event or criteria.   

BAH Priority 
Recommendation 
and Intended Impact		 Consider developing a systematic approach (that is, a strategy and plan) for allocation and tracking of staff during public health emergencies (PHEs) 
“Quick determination of staffing needs and deployment of the right staff to the right place at the right time to maximize review efficiency. Identification of most likely areas for future PHEs (e.g., emerging infectious diseases) and development of process for cross-training to prepare a subset of staff in those areas in the event of a PHE” 
CDRH Perspective 
and Next Steps

CDRH agrees with the recommendation of developing a systematic approach for allocation and tracking of staff during PHEs.  

CDRH is undertaking efforts to proactively prepare for future situations by focusing on how to identify staffing needs and deploy staff to the “right place at the right time” by: 

  • Outlining a blueprint for an Emergency Response Process that will provide guidelines for information sharing, staff mobilization, and operational flexibility with the goal of engaging the right people at the right time in future emergencies.  
  • Starting a process improvement effort to address how ‘Surge Capacity’ is defined and managed in a standardized way across the Center. The goal of this project effort is to define how staff can be seamlessly allocated to work more efficiently during a PHE. Other goals of this project will include how to define situational triggers and thresholds to ‘activate’ a surge capacity situation, as well as how to develop a plan to manage resources through the PHE.   
  • Using a resource pool of qualified contractors to support various activities, including EUA review activities on an ‘as-needed’ basis to address the demands of the PHE.  
  • In addition to identifying ways to manage resource needs, CDRH is exploring ways to simplify and streamline the EUA process. For example, the use of review templates reduced the number of manufacturer submission pages and focused on what was the most important data to submit to the FDA. This helped FDA review staff work more efficiently given the staffing challenges.  

KEY OBSERVATION: There was limited understanding in the test developer community on how to appropriately validate a diagnostic test.  

BAH Priority 
Recommendation 
and Intended Impact		 Consider developing a framework for how to conduct validation of diagnostic tests for emerging pathogens in the setting of a declared PHE 
“[This should result in] Earlier access to accurate and reliable diagnostic tests”
CDRH Perspective 
and Next Steps

CDRH agrees with the recommendation to develop a framework for how to conduct validation of diagnostic tests for emerging pathogens in the setting of a declared PHE. 

CDRH plans to engage with test developers to establish generic templates for commonly anticipated pathogens that may be adapted for potential future outbreaks, as well as a framework for conducting appropriate validation under different circumstances, to speed the availability of future in vitro diagnostic (IVD) devices. CDRH believes that common approaches to validating test design and performance can support development of accurate and reliable tests, regardless of whether there is an emergency. 

CDRH also plans to continue strengthening communication strategies and tools that have proved effective during the COVID-19 PHE, including town halls, webinars, a telephone hotline and email boxes for stakeholder inquiries, templates, and interactions with professional and trade organizations. 

Further, CDRH suggests that the U.S. government consider: 

  • Working with international partners to establish a plan for sharing clinical specimens as soon as a public health threat emerges. Clinical specimens are needed for optimal validation of tests. 
  • Establishing the capacity to independently evaluate test performance before outbreaks occur so that independent evaluation can be performed quickly during an outbreak. CDRH’s collaboration with the National Cancer Institute demonstrated the value of this approach. Combined with FDA emergency use authorization, this strategy could permit rapid independent assessment of molecular diagnostic, antigen, and serology test accuracy and minimize the need for test developers to procure specimens for clinical validation. 

 

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