U.S. Department of Health and Human Services
Office of Inspector General 
FDA Repeatedly Adapted
Emergency Use Authorization
Policies To Address the Need 
for COVID-19 Testing 
 
Suzanne Murrin 
Deputy Inspector General for Evaluation and Inspections  
September 2022, OEI-01-20-00380   U.S. Department of Health and Human Services 
 
Office of Inspector General
Report in Brief
September 2022, OEI-01-20-00380 
Why OIG Did This Review FDA Repeatedly Adapted Emergency Use
At  the start of the COVID-19 
Authorization Policies To Address the Need 
pandemic, no test existed to 
identify this novel virus.  Testing  for COVID-19 Testing  
is vital to diagnose infected 
individuals and understand   When COVID-19 emerged, ensuring 
spread during infectious disease  Key Takeaway  that tests were  available to diagnose 
emergencies. The Food and  From January through May   and track it became a vital public 
Drug Administration  (FDA) used  2020, FDA repeatedly adapted  health goal.  FDA used its EUA 
its Emergency Use Authorization  its approach to how it used   authority to authorize tests and to  
(EUA) authority to  facilitate the  Emergency Use Authorizations  help ensure that the nations testing 
development and availability of  to address COVID-19 testing  needs were met.  The EUA authority 
COVID-19 tests.  Members of  challenges and to expedite  allows for a lower level of evidence 
Congress have expressed strong  access to tests.  However,  these  for emergency medical products
interest in  the availability and  efforts to increase test  compared to during nonemergency 
effectiveness of both diagnostic  availability sometimes came at   situations.  EUAs generally entail a 
and serology tests. This review  a cost to test quality.   shorter review period while 
assesses how FDA used its EUA  maintaining an appropriate assurance 
authority to authorize COVID-19  of quality.  
tests during the crucial first  
Over the first 5 months of the pandemic, FDA issued over 100 EUAs  for 
months of the pandemic.  
COVID-19 diagnostic tests, which identify an active infection, and 
How OIG Did This Review  serology tests, which identify prior infection.  Because of the different 
We focused our review on the  purposes  of these types of tests, FDA used different approaches to 
early months  of the pandemic:  ensure that  tests got to the market quickly and performed well. 
January 1 through May 31, 2020.  
What OIG Found 
We relied on FDA documents,  
The failure of the Centers for Disease Control and Prevention (CDC)s first 
data, and interviews to 
test rollout revealed vulnerabilities in the Federal approach to testing 
determine how FDA  conducted 
early in  the COVID-19 pandemic.  It is  typical for CDC to be the first to 
EUA activities and decision-
receive an EUA, and FDA expected that CDCs test would meet the early 
making. We surveyed and 
testing needs of the nation.  However,  CDCs first test was unusable for 
received responses from 237 test 
many for weeks while no other test was authorized.  Furthermore, due in 
developers that engaged with 
part  to its limited engagement  with  the public health labs that  were using 
FDA about their COVID-19 tests 
CDCs test, FDA was slow to realize that  testing by public health labs was 
and analyzed survey responses 
far more limited than it initially expected.  To address problems with the 
to assess experiences working 
first authorized COVID-19 test, FDA  worked with CDC, including allowing  
with FDA.  We also interviewed 
CDC to modify the terms of its original EUA.  However, preventing a 
test developers and
similar problem from occurring in future emergencies would require 
representatives from a
actions outside of FDAs authority alone.    
professional laboratory
association for context about 
In  using its EUA authority, FDA also made calculated decisions to increase 
developer experiences. 
availability of COVID-19 testing, but  these decisions often came at  a 
potential cost to test quality.  FDA authorized tests using lower levels of 
evidence to support developers struggling to access clinical samples.  
   
FDAs policies allowed diagnostic and serology tests to get on the market 
quickly; however, that resulted in some  problematic tests on the market, 
requiring further action by FDA.  
FDAs decision  to accept all EUA requests resulted in a record number of 
submissionsoften low-quality and from developers lacking experience 
with FDAs processes.  In response, FDA took steps to support developers 
and ease its workload, which included issuing EUA guidance, updating 
templates (submission guides for developers requesting EUA), and 
adjusting its EUA review process, among others.  Some developers still 
reported being frustrated and confused. 
FDAs experience using EUA for COVID-19 tests during the first few 
months of the COVID-19 pandemic provided actionable insights about 
the EUA process as well as a national testing strategy. 
 
Summary of  Actionable Insights  
   FDA addressed early testing challenges using EUA 
flexibilities, but this experience underscores the need for a 
national testing strategy. 
   FDA needs clear, direct communication with the lab 
community during an emergency.  
   Developers require further FDA guidance on how to 
validate tests during shortages of clinical samples. 
   Although policies that delay or forgo FDA review allow for 
faster testing, without FDA review problematic tests reach 
the market.  
   FDA needs contingency plans for resources to handle the 
workload that the next emergency response may require.  
   Templates are useful tools for FDA to communicate 
expectations for test development, validation, and 
authorization.    
   Inexperienced test developers require more support from 
FDA during the EUA process.    
 
 
What OIG Recommends and How the Agency Responded 
Our findings underscore the need to apply actionable insights from FDAs 
early experiences with the COVID-19 pandemic toward current  and future  
infectious disease emergencies to better balance test availability and 
quality. We recommend that FDA:  
 Assess and, as appropriate, revise guidance for test  EUA submissions  
   
 Develop a suite of EUA templates for future emergencies involving 
novel pathogens  
 Expand the FDA Center for Devices and Radiological Healths existing 
device-tracking  platform to facilitate EUA submission and monitoring  
 Expand and improve resources for  test developers on the EUA process 
 Establish formal communication  channels between FDA and the lab 
community, to be used in emergencies that require testing  
 Work with Federal partners to implement lessons learned about a 
national  testing strategy that go beyond the EUA process 
FDA concurred with all of our recommendations. 
 
   
TABLE OF CONTENTS 
 
 
BACKGROUND................................................................................................................................................ 1  
Significant Events in Developing Tests for COVID-19: January Through May 2020 ........................................ 8  
CDCs COVID-19 Test: Highlights of Early Problems ................................................................................................... 9  
FINDINGS....................................................................................................................................................... 10  
FDA used its emergency use authorization flexibilities to help resolve the failure of the CDC test 
rollout, but the engagement revealed vulnerabilities in the Federal approach to early emergency 
testing.......................................................................................................................................................................................... 10  
Facing the need for rapid expansion of COVID-19  testing, FDA eased EUA requirements to further 
speed getting tests to market ............................................................................................................................................ 12  
FDAs decisions to reduce or forgo EUA requirements allowed problematic tests on the market .........16  
A record number of EUA reviews led FDA to adjust its processes to better manage its workload, but 
some test developers were confused and frustrated by these changes ............................................................19  
CONCLUSION AND RECOMMENDATIONS ...........................................................................................27  
Assess and, as appropriate, revise FDA guidance for test EUA submissions ...................................................28  
Develop a suite of EUA templates for future emergencies involving novel pathogens ..............................28  
Expand CDRHs existing device-tracking platform to facilitate EUA submission and monitoring ...........29  
Expand and improve resources for test developers on the EUA process ..........................................................29  
Establish formal communication channels between FDA and the lab community, to be used in 
emergencies that require testing ...................................................................................................................................... 30  
Work with Federal partners to implement lessons learned about a national testing strategy outside 
the EUA process ....................................................................................................................................................................... 30 
 AGENCY COMMENTS AND OIG RESPONSE ....................................................................................... 32  
APPENDIX..................................................................................................................................................... 34  
Appendix: Agency Comments ............................................................................................................................................ 34 
 ACKNOWLEDGMENTS AND CONTACT ............................................................................................... 40  
Contact........................................................................................................................................................................................ 40  
ABOUT THE OFFICE OF INSPECTOR GENERAL. ....................................................................................41  
ENDNOTES................................................................................................................................................... 42  
 
   
BACKGROUND 
OBJECTIVE 
To assess the effectiveness of FDAs use of emergency use authorization (EUA) to 
authorize tests for COVID-19. 
 
In December 2019, a novel coronavirus caused unusual cases of pneumonia-like 
illness in China.  The illness soon came to be known as coronavirus disease 2019 
(COVID-19).1, 2  The Centers for Disease Control and Prevention (CDC) confirmed the 
first domestic case of COVID-19 in a patient in Washington State on January 20, 2020, 
as the virus spread rapidly throughout the world.  In response, the Secretary of Health 
and Human Services declared a public health emergency on January 31.  The World 
Health Organization declared COVID-19 a pandemic on March 11, 2020, indicating 
that COVID-19 had spread to countries across several continents, potentially affecting 
a large number of people.3, 4, 5  As of May 25, 2022, CDC had reported over 83 million 
cases in the U.S., and over one million deaths.6  
Understanding how infectious diseases spread and whom they infect is paramount to 
containing transmission.7  Testing is one of the most useful tools for disease 
surveillance and for researchers to gain knowledge of the disease such as how it is 
transmitted between individuals. Testing also allows diagnosed individuals to take 
preventive measures to limit transmission to others.  Without sufficient testing, efforts 
to control a virus are significantly limited. 
A diagnostic test for COVID-19 did not exist when the disease first began to spread; 
such is the nature of a novel pathogen.  Therefore, the first step for governments and 
scientists around the world was to develop a diagnostic test.8  Indeed, early in the 
outbreak, FDA stated that it was actively working to facilitate the development and 
availability of tests to diagnose COVID-19, in part through its Emergency Use 
Authorization (EUA) authority.9    
FDAs response to the COVID-19 pandemic is informed by its experiences responding 
to outbreaks of the H1N1, Zika, and Ebola viruses.  COVID-19 has presented many 
new challenges to FDA, and with that, many actionable insights.  This report aims to 
evaluate FDAs use of its EUA authority during the crucial first months of the 
pandemic and to determine opportunities for improvement so that we are better 
prepared for future emergencies.  
 
 
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FDA Emergency Use Authorization Authority 
In part, FDA may use its EUA authority during a public health emergency to allow 
entities to distribute and use unapproved medical products (or unapproved uses of 
approved medical products) for the diagnosis, treatment, or prevention of serious or 
life-threatening diseases.10, 11  This EUA authority allows FDA to facilitate these 
medical products availability to respond to an emergency.  Entities that request EUA 
for their product may seek full approval for the product after authorization.12 To 
initiate FDAs EUA authority during COVID-19, the Secretary of Health and Human 
Services determined that a public health emergency that has a significant potential to 
affect national security or the health and security of U.S. citizens living abroad exists 
and, on the basis of this determination, declared that circumstances exist to justify 
EUA for certain products.13, 14, 15 The Secretary made this determination regarding
COVID-19 and declaration regarding tests for COVID-19 on February 4, 2020.16 EUA 
for a product expires at the end of the relevant EUA declaration, which may extend 
beyond the public health emergency declaration, or sooner if FDA revokes the 
authorization.17,18  
Exhibit 1. FDA must ensure that a product meets four statutory criteria for 
EUA. 
1.   Condition/disease must be serious or life-threatening and caused by the agent 
referred to in the Secretarys declaration; 
2.   It is reasonable to believe based on the available  scientific evidence that the 
product may be effective to prevent, diagnose, or treat such serious or life-
threatening diseases or conditions caused by the agent referred to in the 
Secretarys declaration;  
3.   It is reasonable to believe based on the available  scientific evidence that the 
products known and potential benefits outweigh the known and potential risks, 
taking into consideration the material threat posed by such disease or condition; 
and 
4.   There are no adequate, approved, and available alternatives. 
 
Source: Section 564 of the FD&C Act. 
FDAs EUA authority allows for a lower level of evidence compared to the statutory 
criteria for approval or clearance through a traditional marketing pathway (see 
Exhibit 1).19  Emergency product developers must demonstrate that there is a 
reasonable belief that the product may be effective, rather than that there is a 
reasonable assurance of safety and effectiveness.20, 21, 22   However, developers must
demonstrate a reasonable belief that the products known and potential benefits 
outweigh the known and potential risks.23, 24, 25   This lower level of evidence allowed 
during public health emergencies enables FDA to review and authorize these products 
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more quickly than products approved or cleared through traditional marketing 
pathways.26    
FDAs EUA authority also allows for broad flexibility during an emergency in how FDA 
will balance the need to facilitate the quick availability of medical products with
ensuring that these products meet quality standards.  FDA may do this by engaging 
with stakeholders early in an emergency to encourage them to develop and seek EUA 
for medical products, establishing a required format for EUA submissions, and 
determining how FDA reviewers process EUA requests.  FDA may also be flexible with 
the kinds of evidence standards that developers must meet to receive EUA.   
The COVID-19 response is FDAs most widespread use of EUA authority in response to 
a single threat, though the authority has existed since 2004.27   FDA has used its EUA 
authority in response to such threats as Avian Flu in 2013 and the Zika Virus in 2016.28   
In response to the COVID-19 pandemic, FDA issued EUAs for a variety of medical 
productsfirst for a diagnostic test, and then others to authorize the emergency use 
of N-95 masks, ventilators, and other devices; drug treatments such as remdesivir; and 
three vaccines that are each biologic products.  
COVID-19 Test Regulation Within FDA 
Within FDA, the Center for Devices and Radiological Health (CDRH) regulates medical 
devices, which include products ranging from tongue depressors to pacemakers.29, 30, 31   
CDRH approves and clears medical devices before they are marketed.  It also works 
with the Office of the Chief Scientist to  authorize emergency use of medical devices 
through the EUA pathway.32  Three independent teams within CDRH review COVID-19 
tests: one each for molecular, antigen, and serology tests.33 Other teams carry out
pre-authorization reviews and post-authorization compliance monitoring and 
surveillance.  
Requesting and Issuing an EUA for an Emergency Test 
Before requesting EUA, developers have the option to engage with FDA via a pre-EUA 
process to determine whether their product meets FDAs EUA evidence standards.  
Developers can include government entities (such as CDC), commercial labs, and 
hospital labs.  Pre-EUA activities typically involve FDA reviewing data and documents 
and providing feedback to developers to help ensure that their potential EUA request 
is complete and ready for formal FDA review.34, 35    
To formally request EUA, developers must submit required documents to FDA 
(together, these documents are referred to as an EUA submission or request).36 To 
receive EUA for a test, developers must meet FDAs evidence standards to 
demonstrate that their tests perform as intended (i.e., with a reasonable belief that 
they are effective).37  Meeting these standards requires developers to submit 
validation data to assess the potential for false test results, which can impact the care 
of an individual patient and have public health implications.38 If a developer intends 
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OEI-01-20-00380   Background | 3     
to manufacture a test for distribution, it must also specify the name(s) of the 
manufacturer(s) in their EUA request, which may include contract manufacturers.  
Upon issuing EUA, FDA  establishes conditions of authorization to protect public 
health and safety.39  Developers must adhere to these conditions to continue using 
their test. For example, to ensure that health care professionals understand how to 
use tests and interpret test results, FDA establishes conditions that require developers 
to provide Fact Sheets with this information.  FDA places conditions that require 
developers to collect information on the performance of their test and report 
suspected false test results to FDA.  FDA also establishes conditions requiring test 
users, such as labs, to use the test as specified in the FDA-approved test labeling.  To 
modify their test or how their test may be used, developers must formally request 
authorization for these changes from FDA. 
EUA Post-Authorization Oversight and Enforcement  
FDA reviews authorized products to ensure that they continue to meet the conditions 
of authorization, including that their known and potential benefits outweigh their
known and potential risks, and that products do not jeopardize public health and
safety.40  For COVID-19 tests, FDA post-authorization oversight also involves ensuring 
that all tests on the market have EUA (or do not require EUA to be on the market).  
FDA oversees them by monitoring product performance, watching for signals about 
the products from other sources, and  receiving information from stakeholders.   
FDA gathers information on tests in three ways: receiving allegations of regulatory 
misconduct from stakeholders, direct reporting from developers, and conducting its 
own surveillance. Allegations come from health care providers, patients, and other 
stakeholders, and can include reports of false results or mislabeled products.  
Reporting requirements include data on adverse events and test performance (e.g., 
false positives and false negatives), which developers submit to FDA as data become 
available.  Finally, CDRH reviewers conduct surveillance, such as monitoring websites 
and promotional materials, for tests that are illegally on the market. 
Reviewers begin a compliance investigation if they find evidence or receive 
allegations that a COVID-19 test is being distributed or used in a manner inconsistent 
with the letter of authorization.   FDA may revoke an EUA if the test no longer meets 
the conditions of authorization or presents public health or safety concerns.41, 42     
Diagnostic and Serology COVID-19 Tests  
FDA has authorized two general types of tests to diagnose current infection with, and 
presence of antibodies for, COVID-19: diagnostic and serology.43 Diagnostic tests
identify active infection with COVID-19.  Serology tests determine whether a patient 
had COVID-19 by detecting antibodies in the blood, but should not be used to 
diagnose active infection.44 See Exhibit 2 for details. These COVID-19 tests are in 
vitro diagnostic tests. This means that they use patient samples, such as blood or 
saliva, to indicate whether a patient has COVID-19 or COVID-19 antibodies.  
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Exhibit 2. Types of COVID-19 tests 
Test   Type  Detects  Used to   Result times 
Diagnostic   Molecular  COVID-19  Diagnose active COVID-19    Less than 
genetic material   1 day to
1 week  
Antigen  COVID-19  Diagnose active COVID-19    1 hour or 
proteins  less (may be 
less reliable 
than  
molecular 
tests) 
Serology  N/A  Antibodies in  Indicate prior COVID-19.   Less than 
the blood due  Should  not be used to  1 day to 
to COVID-19    diagnose active COVID-19.    3 days  
Source: FDA, COVID-19 Test Basics.  
Accessed at https://www.fda.gov/consumers/consumer-updates/covid-19-test-basics on September 2, 
2022.   
   
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Methodology 
Scope 
This report focuses on the EUA process during the first few months of the COVID-19 
health emergency. It includes all COVID-19 tests that FDA reviewed for authorization  
from January 1 through May 31, 2020, and oversight FDA conducted on those tests 
through December 31, 2020.  Although FDA does not know the exact number, it 
estimates that by late May 2020 it worked with more than 400 developers through the 
pre-EUA and EUA processes and issued 117 EUAs for tests.45  FDA has continued to 
issue EUAs after the review period of this evaluation.  As of May 3, 2022, FDA issued
EUAs for over 400 tests, including 348 diagnostic and 85 serology tests.46 
To conduct this study, we relied on multiple data sources: public and internal FDA 
documents; interviews with test developers, FDA staff, and other stakeholders; and a 
survey of test developers. 
FDA Documents 
We received data from FDA on its EUA policies and procedures, such as its standard 
operating procedures for EUAs; all policies and procedures for requesting, reviewing, 
and prioritizing EUA submissions; criteria for review decisions; and documents related 
to oversight and enforcement, among other data.  We also received a log of all test 
developers that engaged in EUA and pre-EUA activities with FDA between January 1 
and May 31, 2020. In addition, we acquired publicly available data, such as guidance 
documents, lists of tests that received EUA, and information on tests that were subject 
to oversight enforcement actions.  
Interviews 
We conducted interviews with four test developers and 11 FDA staff members, 
including reviewers and officials within CDRH.  We also conducted interviews with 
other stakeholders, including a former FDA official and staff from a professional 
laboratory association.  We use the data from the test developer interviews as 
examples and to provide context, but do not use them to generalize to all test 
developers that sought EUA for COVID-19 tests.   
Test Developer Survey 
We sent a web-based survey to all test developers that contacted FDA about the EUA 
or pre-EUA process between January 1 and May 31, 2020.  FDA provided us with a list 
of all EUA and pre-EUA submissions, including a contact email address for each 
submission. 
We sent our survey to all 967 unique email addresses on the EUA/pre-EUA log 
provided by FDA.  However, FDA informed us that the 967 email addresses may not 
represent 967 unique test developers.  Rather, some developers used unique email 
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OEI-01-20-00380   Background | 6     
addresses for each EUA or pre-EUA request they submitted, and others requested 
EUA or pre-EUA for the same test multiple times using different names.  FDA also 
informed us that the log contains some test resellers and distributors that submitted 
EUA requests for tests that FDA had already reviewed.  Therefore, we do not know 
(nor does FDA) the true population of unique test developers that contacted FDA 
about COVID-19 tests. 
Many of the contact emails on the list FDA provided were for contractors that test 
developers hired to act as intermediaries for working with FDA.  Several contractors 
submitted multiple EUA applications for multiple test developers.  Because we sought
information about test developers direct experiences with FDA and the EUA process, 
we did not collect responses from contractors. Instead, we requested contact 
information for the test developers with whom they worked, but only 22 out of over 
100 contractors responded.  We sent the web-based survey to all test developers 
identified by the 22 contractors.  
In total, 237 test developers responded to the survey.47 Therefore, data from the 
survey represent the views and experiences of the 237 test developers that responded 
to our survey rather than all test developers that contacted FDA about an EUA for 
their test. 
In the survey, we asked questions about the developers experiences working with 
FDA, including whether FDAs guidance, processes, and policies were helpful or 
challenging. We also included several open-ended response options for developers 
to provide more context about their experiences.   
Analysis 
We analyzed data provided by FDA to assess how FDA implemented EUA policies and 
procedures and to construct a timeline of significant events related to EUAs for 
COVID-19 tests in the first five months of 2020. 
We analyzed interview data with test developers to inform the questions we asked in 
our test developer survey.  We also analyzed the interview data and the survey results 
to provide context about the developer side of the EUA process.   
Limitations 
The results of our test developers survey are not projectable and only reflect the 
experiences of the 237 test developers that responded to the survey.   
Furthermore, we did not independently verify data provided by FDA, nor information 
provided by FDA or test developers in interviews.   
Standards 
We conducted this study in accordance with the Quality Standards for Inspection and 
Evaluation issued by the Council of the Inspectors General on Integrity and Efficiency. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380   Background | 7    Significant Events in Developing Tests for COVID-19: January 
Through May 2020 
For reference throughout the report, below are some key events that took place 
during the scope of our study, followed by an overview of early problems with CDCs 
test. 
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CDCs COVID-19 Test: Highlights of Early Problems   
CDC develops a test  for COVID-19:  On January 9, 2020, FDA and CDC began 
discussing the COVID-19 pandemic, including CDCs progress toward developing a 
test. 
FDA authorizes CDCs test: On February 4, FDA issued EUA for CDCs test, a day  after 
receiving CDCs complete submission for authorization.   
PHLs report a problem with the test: On February 10, days after CDC made its test 
available to 115 labs, including PHLs and Department of Defense (DoD) labs, CDC 
notified FDA that 10 PHLs were reporting problems with one of the four components 
of the testthe N3 component.48, 49  Each component has its own function in the test.  
The N3 component was included to identify any virus in the coronavirus family that 
causes severe acute respiratory syndrome (SARS) in case COVID-19 mutates.  
Two days later, CDC reported to FDA that 26 PHLs had problems with the N3 
component. On February 15, CDC reported that additional PHLs had problems with 
the N1 component (on February 21, CDC clarified that six labs had issues with the N1 
component). PHLs were unable to use tests that had problems; however, some labs, 
including CDC itself, were able to continue testing.   
Some PHLs reported problems with two components of CDCs test.  
    
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FINDINGS 
FDA used its emergency use authorization flexibilities to help
resolve the failure of the CDC test rollout, but the engagement 
revealed vulnerabilities in the Federal approach to early 
emergency testing 
As previously noted, FDA issued the first EUA for a COVID-19 diagnostic test to CDC 
on February 4, 2020. CDC was the first test developer to request and receive EUA, 
which is typical because CDC is often the first U.S. entity to obtain samples for novel 
pathogens. Obtaining these samples allows developers to validate their tests, a key 
element of an EUA request because it demonstrates that the test performs as 
intended.50  Thus, CDCs early access to clinical samples gives it a considerable head 
start over commercial developers. Even so, CDC was not able to obtain a sample to 
validate its test until it identified a case in the U.S.  
CDCs position as the only developer with an authorized COVID-19 test proved 
problematic when PHLs reported concerns with certain components of the test.  
Although FDA noted a robust pipeline of
private developers interested in 
We were working with CDC daily to 
requesting EUA for COVID-19 tests in 
January and February 2020, CDCs was  explore various options to address the 
the only test in the nation with EUA until  problems observed with their 
February 29. With no Federal plan to fill  distributed test... We had reviewers on 
the gap in testing when the CDC test   standby through the weekends, ready 
failed, FDA worked with CDC to solve the  to review such requests.  FDA official 
problems while continuing to engage
with private developers. 
FDA allowed modifications to CDCs existing EUA to address problems and increase 
testing. FDA and CDC agreed on a dual approach to resolving this issue; both 
approaches would require authorization from  FDA.  First, during a February 10 call,
CDC told FDA that it suspected the problem occurred during the manufacturing 
process. To address this, FDA and CDC agreed that commercial vendors could 
manufacture CDCs test or problematic components of CDCs test.  CDC initially used
its own facilities to manufacture its COVID-19 test.  FDA suggested that CDC request
to include two contracted manufacturers in its EUA.  Once FDA approved that, the
contractors produced and distributed millions  of CDCs tests within weeks.  Second, 
on February 15, CDC began considering contingency plans that would require further 
modifications to its existing EUA so that PHLs could use the tests they had until the 
replacements arrived.  On February 26, after receiving data from CDC confirming that 
dropping the N3 component would not adversely affect test results, FDA allowed 
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PHLs to drop the N3 component if they had problems with only this component of 
the test. FDA drafted proposed instructions for PHLs and, together with CDC, 
communicated that PHLs could proceed with testing in this way.51  
FDA had to take additional steps to ensure that CDCs EUA modifications were 
appropriate. After learning on February 21 that CDC had not yet confirmed the cause 
of the problem, FDA immediately sent an official onsite to CDC laboratories to 
conduct FDAs own assessment. Identifying a manufacturing problem would allow 
FDA and CDC to continue with their approach to resolving this problem; identifying a 
design problem would require CDC to seek authorization for a new test.  The FDA 
official ultimately concluded that CDCs test design was sound and the problem was 
caused by contamination during manufacturing.   
Overall, to address the problems with the CDC test rollout, FDA used its EUA authority 
to an extent that it had not in previous emergency responses.  Notably, FDA and CDC 
worked closely throughout February and March to pursue opportunities to expand 
access to testing under CDCs EUA. As one FDA official put it, In all, there were 
several actions underway simultaneously, all of which were targeted to increasing 
testing capacity. See Exhibit 3 for other examples of how FDA engaged with CDC. 
Exhibit 3. Examples of how FDA worked with CDC to increase the availability 
of diagnostic tests under CDCs EUA  
 
  Facilitated negotiations between CDC contract manufacturers to ensure that research use only tests  
could be offered for immediate clinical use under CDCs EUA. 
  February 27: CDCs manufacturer began distributing hundreds of research use only tests. 
 
  Proposed and encouraged CDC to allow other EUA developers to use CDCs test design and data to 
demonstrate that their tests performance is comparable to CDCs test. 
February 29: The New York State Department of Health received an EUA using this approach. This 
was expanded to all developers in March.    
 
  Encouraged CDC to allow any lab to use kits manufactured under CDCs EUA.   
First week of March: Over 1 million tests released.  
Second week of March: Over 5 million tests released.  
Third week of March: Over 10 million tests released.  
 
Source: Document submitted to the Homeland Security & Governmental Affairs Committee (2021). 
 
Because FDA was only directly engaged with developers through its EUA process, FDA 
was slow to  realize that testing within PHLs was far more limited than it had initially 
expected. Regarding authorized tests, FDA communicates directly with developers, 
not with the labs implementing them.  For this reason, FDA was not initially engaged 
with PHLs.  As a result, FDA was unaware that testing within PHLs was very limited and 
may not have provided sufficient testing.  FDA assumed that dozens of PHLs, in 
addition to CDC, were using CDCs original test and could meet the testing needs of 
the nation until other test developers received authorization for their own tests.  
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Findings | 11     
However, FDA learned from media sources that far fewer PHLs were testing than 
expected. On February 21, when FDA requested clarification from CDC about the use 
of the authorized COVID-19 test, CDC surprised FDA by reporting that only seven 
PHLs were using the test. CDC assured FDA that the testing at these seven sites and 
increased testing capacity in CDCs Atlanta facilities were meeting the needs of the 
nation.52  
On February 24, FDA was again alerted to the possibility that U.S. testing needs were 
not being met by the CDC test. The Association of Public Health Laboratories (APHL) 
wrote to then FDA Commissioner Dr. Stephen Hahn to urge FDA to allow certain PHLs 
to immediately start using non-CDC tests developed in their own labs.53, 54 Letters 
from APHL and other stakeholders also led FDA to recognize that many in the lab 
community did not know that they could have sought EUA for their own tests.55 After 
receiving APHLs letter, FDA began to join regular calls between CDC and APHL.  FDA 
also started to consider policies to speed up test availability. 
Actionable Insights 
 
   FDA addressed early testing challenges using EUA 
flexibilities, but this experience underscores the need for a 
national testing strategy. 
   FDA needs clear, direct communication with the lab 
community during an emergency.  
 
 
Facing the need for rapid expansion of COVID-19 testing, FDA
eased EUA requirements to further speed getting tests to
market   
As COVID-19 spread across the country, robust testing became increasingly urgent.  
The demand for diagnostic tests was growing exponentially and the pressure was 
high for FDA to take steps to immediately increase diagnostic test availability.  This 
urgency increased after FDA learned that not as many PHLs were using CDCs test as 
expected. In addition, serology tests were in demand to help researchers understand 
COVID-19 immunity and how the disease spreads.  
To respond to this need, FDA took advantage of the flexibilities in the EUA process to 
address testing challenges the country was facing.  Although the EUA process already 
allows developers to get their tests to the market faster than through traditional 
marketing pathways, FDA further eased various EUA requirements.  
 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Findings | 12    To help developers overcome clinical sample shortages, FDA 
authorized tests using lower evidence standards 
In mid-February 2020, FDA learned that developers were struggling to access clinical 
samples needed to validate tests, preventing them from requesting EUA.  Although
limited access to clinical samples is a typical problem when infectious diseases 
emerge outside of the U.S., this challenge became even more urgent in the wake of 
the CDC test rollout failure.  Some samples were available in mid- to late February; 
however, only certain developers, such as those qualified to handle live viral material, 
could access the material. The larger developer community had limited access to 
clinical samples, or other kinds of acceptable validation material, until mid- to late 
March. Indeed, of the developers that responded to our survey and attempted to 
obtain validation material, 77 percent (173 out of 226) found obtaining validation 
materials to be challenging or somewhat challenging.  FDA staff also told us that 
accessing validation material was the most common challenge reported to FDA early 
in the pandemic. 
FDA responded by using its EUA
flexibilities.  FDA accepted 
[The smaller set of samples] is just really, 
validation studies that used 
really a low bar.  But [the] EUA process allows
contrived samples to help test 
us to do that and match our requests to the
developers overcome 
situation on the ground.  FDA official 
challenges accessing clinical 
samples. This was more 
achievable for developers, while
still demonstrating acceptable performance.  On February 29, FDA announced that it 
would recommend that developers use a smaller set of patient samples, which FDA 
determined was just enough to be able to demonstrate acceptable performance.  FDA 
also recommended that developers use more contrived samples than previously 
required.56, 57  A contrived sample is made by spiking human specimens with COVID-
19 material (such as inactivated virus).58, 59 Although contrived samples are easier to
access, they are less reliable than patient samples.60  In total, FDA authorized 59 EUA 
requests based on validation using contrived samples, although in May 2020 FDA 
began to recommend clinical samples for validation since these were more easily 
available at this point. 
Although FDAs approach addressed the challenges of validating tests and getting 
them on the market faster, FDA also recognized that this approach introduced 
potential uncertainty into test results.  As one FDA reviewer stated, at the beginning 
of an outbreak we do have to compromise, and thats really the nature of the 
outbreak. To help address this uncertainty, FDA sent standardized validation 
material to all molecular test developers, including those that previously used 
contrived samples as well as those seeking EUA.  Using this material allowed potential 
users of tests to compare performance results among tests. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 13   Actionable Insight 
Developers require further FDA guidance on how to validate 
tests during shortages of clinical samples. 
FDA allowed test developers to delay or forgo EUA review so that 
they could immediately begin testing 
FDA made several policy announcements to quickly increase the availability of tests
(see Exhibit 4).  These policies were notification policies, which meant that 
developers could delay or forgo FDA review and begin testing or distributing their 
tests right away, as long as they notified FDA and validated the tests first. 
Within a week of FDA issuing the February 29 notification policy, which allowed 
qualified labs to begin testing before submitting an EUA request, seven labs notified 
FDA that they would begin testing. By late March, 65 labs notified FDA that they 
would test under this policy, and by May 11, 2.5 months after the original policy 
announcement, this increased to 245 labs.61, 62  
Unlike the February 29 notification policy, FDAs March 16 notification policy for 
commercial diagnostic test manufacturers generated little interest.  An FDA official  
told us that relatively few commercial manufacturers took advantage of the policy and 
most chose to proceed with an EUA request before distributing their tests.  While it is 
unclear why so few chose to take advantage of this policy, one developer that 
completed our survey and chose this route noted that, because its test had not yet 
received formal EUA, insurance payers did not pay for it.63  Developers are also 
qualified for certain liability protections under the Public Readiness and Emergency 
Preparedness Act when their tests have EUA.64  
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 14   Exhibit 4. FDA issued five notification policies to increase test availability.* 
Type of test   Date  Developers   Details  
February 29  Certain labs  Before use, qualified labs must validate the 
Diagnostic   qualified for high- test; notify FDA via email; submit a full request 
complexity work   for EUA within 15 business days of notifying 
FDA.  
March 16   Commercial  Before use and distribution, developers must 
manufacturers  validate the test; notify FDA via email; submit 
a EUA request within  15 business days of 
notifying FDA.  
Serology  March 16  All developers  No EUA required if developer validates the 
test; notifies FDA; provides appropriate 
information with  the test 
May 4   Commercial  Revision  to  March 16 serology policy.  Before 
manufacturers  use and distribution, developers must validate 
the test; notify FDA via email; submit a full 
request for EUA within 10 business days of 
notifying FDA.  
All tests65   March 16   Certain labs  FDA granted flexibility for States to oversee 
(March 12 for  qualified for high- COVID-19 tests developed and used by 
New York)  complexity work   qualified labs within  that State if the State 
notifies FDA first.   
*FDA no longer allows additional developers or States to use any notification policy as of November 15, 2021.
Source: FDA Statements made on February 29, March 16, and May 4, 2020.66, 67, 68 
FDAs initial notification policy for serology tests, issued on March 16, allowed 
serology tests on the market with even more relaxed requirements than those for 
diagnostic tests. In mid-March, FDA stated that the value of serology tests lies mainly 
in advancing the scientific communitys understanding of COVID-19.69, 70 Serology
tests cannot be used to diagnose an active infection with COVID-19 and had limited 
use in prior emergencies.71  Therefore, FDA made a strategic decision to focus its 
limited resources on authorizing diagnostic tests rather than serology tests.  The 
March 16 notification policy stated that serology test developers could request EUA 
for their tests or put their test on the market without EUA if the developer met certain 
conditions.  To help ensure that serology tests were used appropriately, FDA limited 
this policy to certain qualified labs.72, 73, 74 By the end of April, 164 commercially
manufactured serology tests were on the market via the notification policy.75   
To help test developers respond to supply shortages, FDA 
allowed developers to forgo seeking EUA amendments for 
substituting supplies  
When shortages emerged in March 2020, FDA recommended that developers use 
substitute supplies without an EUA amendment, which typically would have been 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 15   required. Manufacturers struggled to keep up with demand for certain supplies, such 
as reagents and nasal swabs, which the U.S. National Stockpile does not stock.  When 
a developer demonstrated that an alternative product could be an acceptable 
substitute, FDA recommended that other developers make these substitutions 
without requesting an EUA amendment.  To further support national efforts to 
address the supply shortage, FDA staff prioritized reviewing EUA submissions for tests 
that did not rely on supplies that were difficult to access.   
FDA also took steps outside of its traditional role to ease supply shortages.  Although
FDA does not traditionally procure supplies, FDA worked with other government 
entities, including the Department of Defense (DoD) and the Federal Emergency 
Management Agency, to advise and coordinate procuring supplies.  FDA worked with  
the Biomedical Advanced Research and Development Authority (BARDA) and DoD to 
coordinate military airlifts of swabs out of northern Italy to the U.S.  In addition, FDA  
contacted over 1,000 manufacturers to gain insights on shortages and potential 
shortages, although it heard back from only around a third.76   As one FDA official 
described FDAs approach to addressing testing supply shortages, FDA was actively 
seeking and promoting different solutions to meet... the needs on the ground.  
FDAs decisions to reduce or forgo EUA requirements allowed 
problematic tests on the market 
FDA successfully used the flexibilities in the EUA process to help make more tests 
available faster.  However, when FDA allowed labs to use tests before requesting EUA, 
or to not require EUA at all, problems arose.   
FDA found that many diagnostic tests on the market via the 
notification policies had performance problems 
FDA identified numerous tests with potential performance problems after issuing its 
notification policies for diagnostics tests.  Indeed, although FDA designed its 
notification policies to expedite access to diagnostic tests, it was aware of potential 
tradeoffs with poorer test performance.  Of the seven labs that notified FDA in the 
first week after the February 29 notification policy that they were going to start 
testing and submit an EUA request later, one lab ultimately withdrew its test due to 
contamination and three other labs had design or validation problems with their tests.  
A later FDA analysis of 125 EUA requests for lab-developed diagnostic tests found 
that 82 tests had design or validation problems.  FDA identified similar problems with  
commercial tests.77    
Problematic tests were on the market and being used for the time span between 
notification and FDA review and action.78 Weeks or months may have passed before
FDA reviewed the EUA request and required a developer to correct performance 
problems. This may have led to patients receiving false positive or false negative test 
results; the public health implications of the policy remain unclear.  In addition, 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 16   because tests on the market via notification policies had not yet received EUA, 
developers of these tests did not have to meet conditions of authorization to report 
test performance concerns.  To counter the delay in identifying problems, in May 
2020 FDA began prioritizing review of tests on the market via the notification policy.  
FDA determined that allowing developers to market serology 
tests with no EUA led to a concerning number of poorly 
performing and inappropriately marketed serology tests, which 
required FDA action 
Removing the requirement for EUA review allowed problematic serology tests on the 
market. By April 2020, around a month after the policy was announced, FDA became 
aware of a flood of poorly performing and inappropriately marketed serology 
tests.79, 80  Some tests did not perform as expected, and others came with false claims 
to diagnose COVID-19 or to have FDA approval (no serology test for COVID-19 had 
FDA approval).  Stakeholders were also using or considering using serology tests for 
purposes outside of advancing scientific knowledge.81, 82  FDA officials have since 
publicly stated: in hindsight, however, we realized that the policy outlined in our 
March 16 guidance was flawed and point to this experience to show the importance 
of EUA review.83  
Spurred by concerns about serology 
tests already on the market, FDA began 
Its to our knowledge that this is the  
to take actions.  By the end of April, 
first time the U.S. government has 
more than 150 serology tests were on 
formally done testing of [in vitro
the market without EUA.84 That month, 
diagnostic] products and used that 
FDA issued a letter to health care 
testing to make regulatory decisions. 
providers cautioning them against using 
 FDA official 
serology tests for diagnostic purposes
and warning them about mislabeled 
tests.85, 86 It also announced a 
partnership with the National Institutes of Health, CDC, and BARDA to validate 
serology tests within the National Cancer Institutes (NCIs) labs.  FDA worked with 
NCI to evaluate commercial manufacturers serology tests, both those already on the 
market via the notification policy and tests not yet on the market for which FDA 
needed additional data to support an EUA.  FDA  used the raw data sent by NCI to 
inform its regulatory decisions.87  FDA posted performance reports for each evaluation  
on its website.88  By early 2021, FDA found that two-thirds of EUA requests for 
serology tests that NCI evaluated did not have adequate performance data. 
FDA took further action in May by requiring EUA review for certain tests already on 
the market. At this point, only 12 of the dozens of tests on the market had 
undergone EUA review (developers could still choose to request EUA under the March 
16 notification policy).89  On May 4, FDA announced a notification policy requiring 
commercial serology test manufacturers to request EUA within 10 business days of 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 17   putting validated tests on the market, including tests already on the market.  
Developers could still use and distribute their tests after requesting EUA.  FDA  
required manufacturers that chose not to seek EUA to suspend distribution of their 
tests.90, 91  In March, it created an online list of serology tests that it permits to remain 
on the market. 92, 93  By November 2020, FDA had removed 167 serology tests from 
this list.  
In addition, most FDA post-authorization actions related to COVID testing in 2020 
were for serology tests (see Exhibit 5). For example, FDA issued import alerts for 
nearly 80 inappropriately marketed serology tests that manufacturers from other 
countries were attempting to sell in the U.S.  FDA issues import alerts to the public; 
devices on the import alert list are detained at the border and prevented from 
entering circulation until FDA receives evidence to overcome the appearance of the 
violation.94  
Exhibit 5. Throughout 2020, most post-authorization actions to address 
mislabeling and performance concerns for COVID-19 tests were for serology 
tests.  
*Voluntary recalls are initiated by the manufacturer and conducted in accordance with 21 CFR Part 806.
**This does not include two warning letters for entities offering violative serology and diagnostic tests. 
Source: FDA data provided to OIG. 
Actionable Insight 
Although policies that delay or forgo FDA review allow for faster 
testing, without FDA review problematic tests reach the market. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 18   A record number of EUA reviews led FDA to adjust its processes 
to better manage its workload, but some test developers were
confused and frustrated by these changes 
From January through May 2020, as demand for tests skyrocketed, FDA reviewed all 
EUA requests, regardless of the submissions quality.  An FDA official explained: In 
the absence of a national testing strategy, ...we had to take an all-comers approach 
and its one of the reasons why there were so many tests authorized in the U.S. 
marketplace. FDA reviewers interacted with developers primarily over email, working 
nights and weekends to authorize as many COVID-19 tests as possible.  FDA 
developed new strategies to manage this unprecedented workload, but FDA staff 
were already overloaded with review work while they were spending additional time 
developing these strategies. In addition, some of FDAs efforts frustrated and 
confused test developers. 
FDA reviewed a record number of EUA requests for COVID-19 
tests, including a high number of low-quality submissions 
Test developers inundated FDA with requests for EUAs in the first few months of the 
pandemic. According to an FDA official, FDA microbiology division staff process 
around 100 in vitro diagnostic test applications in a typical, nonpandemic year.  
During this studys time frame of January through May 2020, FDA staff received over 
100 EUA requests per month for 3 consecutive months (see Exhibit 6), which was in
addition to their usual device approval work.  In January 2021, nearly a year after the
public health emergency began, the FDA official told us the volumes of requests were 
still over 100 per month. 
Exhibit 6. EUA requests for COVID-19 tests increased substantially from 
February through May 2020. 
Note: FDA did not receive any EUA requests in January 2020. 
Source: FDA data provided to OIG.  
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 19   During the first year of COVID-19, FDA issued more EUAs for tests than during all 
prior emergencies combined. For example, during the H1N1 influenza pandemic of 
2009, the last pandemic to affect a large number of people in the U.S. prior to 
COVID-19, FDA issued 17 EUAs for H1N1 tests in a 12-month period.95 In 
comparison, during the first 12-month period of the COVID-19 pandemic, FDA issued 
320 EUAs for COVID-19 tests.96  During our review period, January-May 2020, FDA 
authorized 117 tests (see Exhibit 7), and over the following 12 months, it authorized 
an additional 101 of the 731 tests that developers submitted for authorization during 
our review period. 
Exhibit 7. FDA issued over 100 EUAs for COVID-19 tests by the end of May 
2020. 
Note: FDA did not issue any EUAs for COVID-19 tests in January 2020. 
Source: FDA data provided to OIG. 
Furthermore, FDA staff reported that most EUA submissions were low-quality, and this 
contributed to reviewer workload.  Low-quality 
EUA submissions include those that were missing 
necessary data or contained data that failed to  A lot of the submissions we 
meet FDAs standards.  FDA reviewers  got were very poor quality
communicated with test developers, requesting  and all of that ate up our 
additional data and studies, until they could  time.  FDA official  
determine if the test met authorization standards. 
One lead reviewer estimated that 80 percent of 
submissions needed revisions. 
Finally, developers inexperienced with FDAs processes also took FDA reviewers time, 
which contributed to their heavy workloads.  One reviewer told us, its smaller device 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 20   manufacturers and laboratories who have not interacted with the regulatory 
environment much before, who struggle meeting our criteria.  In fact, most test 
developers that responded to OIGs survey indicated that their experiences with FDA 
were limited: only 13 percent of respondents (31 of 237) had requested an EUA for a 
non-COVID-19 product in the past and just 28 percent of respondents (67 of 237) had 
gone through any FDA approval or clearance process at all.  Experience appeared to 
help developers: 91 percent of survey respondents who had experience working with 
FDA on both an EUA and a regular device approval (20 of 22) received EUA for their 
first submitted COVID-19 test, compared to 40 percent of those with no experience 
(64 of 159).  One FDA staff member who was responsible for responding to emails 
full-time for the first few  months of the pandemic told us that those with less 
experience had no idea... how things should be done and required another level of 
support.  
Actionable Insight 
FDA needs contingency plans for resources to handle the
workload that the next emergency response may require. 
FDA spent time and resources offering special assistance to make 
the EUA process clear and accessible to test developers, but 
developers voiced concerns about evolving expectations  
Facing the urgent need for authorized tests, FDA took steps to make the EUA process 
clear and accessible to potential developers, many of which had never worked with 
FDA.  
Templates.  FDA developed templates for test developers to use in submitting EUA 
requests to FDA for COVID-19 tests.  These templates provided a roadmap for
developers to meet FDAs standards for test development, validation, and 
authorization.97 FDA created the templates based on feedback it had received from
test developers in prior emergencies in which developers reported that FDAs 
processes were not transparent.  
Many test developers that responded to OIGs survey benefitted from the templates 
(see Exhibit 8).  For example, one test developer volunteered, The difficulty was prior 
to Feb 29, 2020 when the obstacles were so high that we could not apply for an EUA 
and thus had no testing. When FDA changed the requirements and provided a 
template, it was much more straightforward.  Another explained how helpful it was 
to have a template to follow, saying it was very clear in laying out exactly how we 
needed to validate our test and how we needed to present our validation data. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 21   Exhibit 8. Developers who responded to OIGs survey found FDAs COVID-19  
test templates accessible and helpful. 
*191 out of 233 developers that accessed a test template
**222 out of 232 developers that used a templates requirement instructions
Source: OIG analysis of OIG survey data. 
By May 31, FDA had revised one of its templates six times.  FDA streamlined its 
original template for molecular tests by reducing it from 30 to 9 pages.  FDA also 
modified the template to reflect new information and situations, such as knowledge 
about the virus or test component shortages.  For example, FDA modified the 
template to recommend contrived samples for validating a test, and then modified it 
again when clinical samples were more widely available.  This meant that a test 
developer that submitted its EUA request under the contrived samples template could 
be surprised to find that FDA would no longer accept its data by the time FDA began 
its review. The developer would then have to redo the same experiments with clinical 
samples to meet the requirements of the new template. 
Adapting to FDAs changing
templates proved frustrating for 
Between when I submitted my application 
some developers. In fact, 65 
for EUA and when it was reviewed, the 
percent of developers that 
template was changed.  I found it difficult
responded to our survey (153 out 
to follow the process, to know what was 
of 237) indicated that adapting to 
FDAs changing requirements was  expected of my lab, and to keep up with 
challenging or somewhat   the changes.  Test developer, OIG survey 
challenging. In addition, FDA did 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 22   not provide a template for antigen tests (e.g., rapid tests for home use) until May 11, 
2020. Staff at one antigen test developer told us they were frustrated by FDAs 
expectations for antigen test authorization, which they found particularly unclear prior 
to FDA releasing the antigen template. They, along with other survey respondents, 
reported having to resubmit data several times only for FDA to move the goalpost 
and deny EUA. 
Nevertheless, FDA officials told us that the templates for the COVID-19 test EUA 
requests, and their revisions, allowed them to streamline their review and enabled 
authorization to occur more efficiently. Over time, templates came to include enough 
detailed information for test developers to submit a complete EUA request with 
minimal interaction with reviewers, including via pre-EUA.  FDA emphasized the
importance of creating templates that target different pathogens in advance of 
emergencies as a key lesson learned from this pandemic.   
Guidance documents.  FDA published guidance and updated policies on its website 
to further support test developers.  For example, FDA published Policy for 
Coronavirus Disease-2019 Tests During the Public Health Emergency on February 29, 
2020, and revised it several times.  Although 89 percent of test developers that 
responded to OIGs survey (210 of 237) found the documents helpful or somewhat 
helpful, 65 percent (154 of 237) found keeping track of updates to FDAs EUA policies 
challenging or somewhat challenging.  One developer volunteered that it is
frustrating and costly... when new guidance or requirements are issued constantly.  
Another was more specific in its criticism: Conflicting guidances and being held to 
changing requirements in the EUA template dictated that experiments were 
performed multiple times at significant expense.  This was not tenable and disrupted 
patient testing during the early stages of the pandemic. 
Electronic submissions.  FDA changed its longstanding protocol of requiring 
developers to deliver all EUA requests in hard copy form.  Experienced developers 
were accustomed to this requirement, but those that had not worked with FDA found 
it overly burdensome. Because this was a barrier for some developers during a time 
when the country urgently needed tests, FDA began accepting all submissions 
through email in February 2020.  
Dedicated email boxes for test 
developers.   To help manage the 
influx of emails from potential test  I cannot emphasize enough the 
developers, FDA  initially created  convenience and how truly nice it was to 
a general email box for stakeholders have supplements and amendments be 
to direct questions about tests,
submitted to specific email boxes.  
supply shortages, and the EUA 
Test developer, OIG survey 
process. Because test developers 
quickly inundated the inbox with 
thousands of emails, FDA assigned  
two people  to staff the email box 18-plus hours per day.  FDA went further and 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 23   created dedicated email boxes for specific aspects of the EUA process, such as an 
email box for test developers that had received an EUA to send amendment 
submissions when changes to a test became necessary.  Of test developers that
responded to our survey and used the email boxes, 89 percent (185 of 207) found 
them helpful or somewhat helpful.  One developer told us it sent a few questions to 
the general email box and whoever was working on that email box was very 
responsive.  
Town Halls.   In March 2020, FDA began holding 
weekly virtual Town Halls to provide developers the 
[T]he weekly FDA town hall 
opportunity to ask technical questions about 
calls that are ongoing have 
developing and validating COVID-19 tests.  FDA
been a tremendous resource! 
also used Town Halls as an opportunity for experts 
 Test developer, OIG survey 
to make announcements, answer general 
questions, listen to concerns to address on the call
or take back to the Agency to consider, and give 
developers insight into its  review processes.  An FDA official said all the major 
associations and other stakeholders participated; the official called the Town Halls a 
great way to reach in the community very quickly.  Of test developers that responded 
to our survey and participated in the Town Halls, 89 percent (167 of 187) found them 
helpful or somewhat helpful.  
Frequently Asked Questions section of FDAs website.   FDA added a FAQ 
section to its website in March 2020 to address questions related to COVID-19 tests 
and the EUA process. FDA updated the FAQ page frequently to address questions it 
received through emails.  Of test developers that responded to our survey, 89 percent 
(211 of 237) found the FAQs helpful or somewhat helpful.  For some, the FAQ page 
became a go-to source for updated information during the rapidly evolving 
pandemic. For example, one developer we interviewed would review the FAQ page 
every single morning during the first year of the pandemic.  
Actionable Insights 
  Templates are useful tools for FDA to communicate
expectations for test development, validation, and
authorization. 
  Inexperienced test developers require more support from
FDA during the EUA process. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 24   FDA eased staff workload by adjusting its internal review process; 
test developers voiced frustration with a lack of transparency 
regarding these changes and the review process 
In the face of the highest-ever volume of EUA requests, FDA told us it was short on 
staff. To assist reviewers, some staff with infectious disease experience from other 
FDA Centers transferred to CDRH. CDRH was also able to hire staff from outside FDA.   
Still, the volume of EUA submissions overwhelmed reviewersone told us, Our 
workload was unprecedented... Im not sure if Ive ever had 28 submissions on my 
workload.  Not even half that.  This unsustainable workload  impeded FDAs ability to 
effectively respond to the pandemic.  
In May 2020, after months of reviewing all tests submitted for EUA, FDA began 
adjusting internal review procedures to  better manage its increasing EUA-related 
workload. A key component of the revised review procedures was the EUA 
prioritization policy that informally started in May 2020.98  FDA prioritized review for 
tests that could increase accessibility (e.g., at-home tests), could enhance testing 
capacity (e.g., tests that allow processing of thousands of samples per day, per 
instrument), or were already allowed on the market without FDA review.  FDA also 
began to decline to review some tests, such as those that processed low volumes, and 
declined to issue EUA for tests with incomplete EUA submissions rather than allowing 
developers to revise their submissions multiple times.  FDA staff told us that the 
prioritization process was helpful in easing the strain on FDA resources and meeting 
public health needs.  
However, some test developers
reported that FDAs prioritization 
It was difficult to know why the FDA was not 
policy was unclear.  FDA first 
reviewing our application.  It was unclear
communicated the prioritization
what the priorities were for review.  It was 
policy to the developer community 
during a Town Hall in May 2020.   unknown what a company could do to 
Developers that attended Town  escalate review.  Test developer, OIG survey 
Halls reported being confused
about the specifics of the 
prioritization policy. For example,
one developer stated, FDA did not give a direct answer to our questions about how 
they prioritize the applications for review.  In addition, not all developers attended 
Town Halls: 21 percent of our survey respondents (50 out of 237) did not and thus did 
not receive the message. 
Furthermore, some test developers that responded to our survey reported a lack of 
transparency from FDA on the status of their tests reviews.  One stated that it did not 
receive clear or formal communication when our EUA review paused and then was 
rejected as it was similar to an [existing] EUA test.  Others complained about not 
hearing from FDA for weeks or months while they waited for their tests to be 
reviewed. Some survey respondents expressed a desire for FDA to be more 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 25   transparent about the review process, and two specifically suggested that FDA should 
institute a tracking system so developers would know where their tests are in the 
process.  
FDA did not finalize the prioritization policy until October 2020.  By this time, some
developers that received a decline to review decision, meaning their submission was 
deprioritized, had been awaiting FDAs response for 5 months or more. 
In November 2020, FDA took 
further steps to speed review and  [W]e were overwhelmed with submissions 
ease workload on reviewers by  that had issues, and that would just take too 
giving developers 24 to 48 hours  long of a time to be resolved interactively.  So 
to respond to their comments.  
we changed processes and limited the 
According to survey respondents, 
interactive review and set priorities for what 
responding to comments often 
the agency thought would address the public 
includes rerunning studies and 
health need the most.  FDA staff
resubmitting data. If a test 
developer misses the time limit,
then the reviewer may deny 
authorization. Thirty-two percent (76 out of 237) of developers that responded to our 
survey stated that meeting FDAs time frames for data requests was challenging or 
somewhat challenging.  Nevertheless, FDA suggested that limiting interactive review 
relieved workload and allowed reviewers to efficiently manage their EUA submissions.   
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Findings | 26   CONCLUSION AND RECOMMENDATIONS 
FDAs experience using the EUA process during the first few months of the COVID-19 
pandemic provided actionable insights about the EUA process as well as a national  
testing strategy.  
Summary of Actionable Insights  
  FDA addressed early testing challenges using EUA flexibilities, but this
experience underscores the need for a national testing strategy. 
  FDA needs clear, direct communication with the lab community during an 
emergency. 
  Developers require further FDA guidance on how to validate tests during
shortages of clinical samples. 
  Although policies that delay or forgo FDA review allow for faster testing,
without FDA review problematic tests reach the market. 
  FDA needs contingency plans for resources to handle the workload that the
next emergency response may require. 
  Templates are useful tools for FDA to communicate expectations for test
development, validation, and authorization. 
  Inexperienced test developers require more support from FDA during the 
EUA process. 
Robust testing is crucial to responding to emergencies that involve infectious 
diseases. It not only identifies infected individuals but also promotes understanding 
of how a disease spreads.  FDAs EUA authority offers FDA significant flexibility in how 
it can respond to testing needs during an emergency.  FDA took advantage of this 
flexibility to  help address CDC test problems and to increase testing availability.  
However, the U.S.s early reliance on CDC as the sole manufacturer of its test, the 
inability to directly address sample and supply shortages, and resource limitations as 
FDA reviewers attempted to manage the influx of EUA reviews constrained FDAs 
response.  
Balancing the need for test availability with test performance amidst an 
unprecedented pandemic was difficult for FDA to navigate.  No roadmap existed to
achieve that balance, so FDA made calculated decisions that prioritized testing 
availability. This meant that poorly performing tests reached the market, although 
how many were ultimately used or the impact on public health remains unknown.   
Given the early experience of the pandemic, FDA has an opportunity to better plan for 
and respond to current and future public health emergencies. Indeed, FDA has 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Conclusion and Recommendations | 27  expressed its interest to apply lessons learned and be better positioned to facilitate 
testing that balances speed to market with quality.  For example, FDA  officials 
underscore the need for multiple entities to manufacture tests early in an outbreak.  
In addition, FDA is considering steps to ensure a shared understanding of 
nontraditional validation materials, such as synthetic material, to support EUA 
requests. This could include developing formal standards and guidelines on when it 
would be appropriate to use this material.  Finally, an FDA official told us that FDA 
should be more engaged with communications among CDC and the lab testing 
community, including APHL. 
To prepare for and respond to current and future emergencies, we recommend that 
FDA:  
Assess and, as appropriate, revise FDA guidance for test EUA 
submissions 
FDA issued various policies to increase testing availability and to adjust review 
processes to manage increased EUA submission levels.  FDA summarized and 
communicated these policies in a guidance document, which it issued without prior 
public comment because of the need to quickly respond to the pandemic.  FDA 
should assess its use of these policies to determine whether and how it will 
implement them in future emergencies, and revise the policies to reflect lessons 
learned during the COVID-19 pandemic. Specifically, FDA should assess the following 
policies: 
  Developer notification policies: In March 2020, FDA began to allow certain test
developers to use validated tests before requesting EUA. FDA should assess 
the potential use of notification policies in future emergencies, including the
appropriateness of additional safeguards to ensure adequate test performance
for tests that have not yet undergone full EUA review. 
  Prioritization policies: In May 2020, FDA began to adjust internal review
processes to address its increasing workload and to meet public health goals.
However, FDA did not finalize these revised review processes until later in 
2020, leaving many developers confused as to the status of their EUA review.
FDA should determine parameters for reviewing EUA submissions, including
how to prioritize requests, how to communicate prioritization criteria to 
developers, and how to best leverage the criteria to address FDAs workload.
FDA should clearly communicate these parameters to developers. 
Develop a suite of EUA templates for future emergencies 
involving novel pathogens 
Templates were useful tools in the pandemic that supported developers requesting 
EUA for their tests. FDA recognizes the value in creating, in advance of an emergency, 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Conclusion and Recommendations | 28  templates that can be more quickly available to developers.  Rather than developing 
new templates to support test developers as a novel pathogen emerges, as it did with 
COVID-19, FDA should aim to develop a suite of templates that will be ready at the 
start of an outbreak.  FDA should adjust these as appropriate for the specifics of each 
outbreak. FDA should develop templates for both pathogen types that are commonly 
predicted to cause future outbreaks (e.g., from the WHOs list of such pathogens) and 
for various test types, such as rapid antigen tests.  
Templates include key recommendations for how developers should validate their 
tests to meet FDAs requirements. When developing its suite of templates, FDA 
should determine appropriate validation standards for each pathogen and test type.  
This includes determining appropriate alternative validation materials for diagnostic 
tests, such as synthetic material, which developers may need to use to address any 
clinical sample access shortages.  Such standards should include FDAs criteria on 
when it is appropriate to use these materials and what it expects for validating 
diagnostic tests with these materials. 
To ensure transparency with the developer community, FDA should consult with 
stakeholders when developing templates, including validation recommendations, and 
FDA should post templates on its website. 
Expand CDRHs existing device-tracking platform to facilitate 
EUA submission and monitoring 
For the period of our review, FDA managed its largest-ever volume of EUA requests 
primarily over email.  Test developers reported that this sometimes led to confusion, 
including uncertainty about the status of their submissions.  To support developers,
FDA should modify its existing Customer Collaboration Portal (CCP), which allows 
developers to electronically track applications for devices submitted through certain 
traditional marketing pathways.  Developers could use the CCPs existing features to 
view the status of their requests, including their review milestones, rather than 
reaching out to their reviewers for status updates.  This would also reduce the burden  
on FDA reviewers to communicate updates to developers.  FDA could add a data 
submission feature to this tool, which the CCP does not currently have.  This would 
automate and consolidate the EUA submission process into one tool, which would 
help FDA and developers alike.  While FDA has acknowledged the need to explore 
opportunities to modernize and improve its EUA supporting tools, it has not 
established any formal plans to do so. 
Expand and improve resources for test developers on the EUA 
process 
FDA invested significant time and resources during the pandemic to support 
inexperienced test developers.  FDA should develop technical guidance and 
educational material to ease some of its workload during any current and future 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Conclusion and Recommendations | 29  emergency response and to ensure that these resources are available to developers as 
early in an emergency as possible.  To that end, FDA could develop EUA guidance 
tailored specifically to address gaps in developers knowledge and experience, which 
FDA identified during the COVID-19 pandemic.  This guidance could, for example, 
expand on FDA responses to FAQs from developers and provide updated instructions 
for how to access and use templates.  It could also fill in gaps that left some test 
developers confused or frustrated, such as describing what FDA expects EUA 
submission data to look like and explaining  what developers can expect in terms of 
communication from FDA. 
FDA could also consider developing additional educational resources on the EUA 
process. These could include training webinars or step-by-step guides on how to 
request an EUA and how EUA requests are different from traditional marketing 
pathways. By carrying out these activities in advance, FDA will reduce its workload 
during emergencies as developers seek information on the EUA process. 
In addition, FDA should continue the communication strategies that were successful 
during the COVID-19 pandemic to apply to current and future emergencies, as 
appropriate, particularly those that enhanced developer accessibility to FDA.   These 
include Town Halls, FDA email inboxes, and FAQs. 
Establish formal communication channels between FDA and the 
lab community, to be used in emergencies that require testing 
During the COVID-19 pandemic, FDA would have benefited from more direct 
communication with labs. For example, in February FDA was not aware that fewer 
PHLs were testing than it believed. Prior to the next emergency, FDA should work 
with key stakeholders in the lab community, such as APHL and the American Clinical 
Laboratory Association (ACLA), to determine how to communicate during and in 
advance of a public health emergency.  FDA could consider creating regular forums
for connecting during emergencies, including setting up protocols and expectations 
for when to initiate communications.  During emergencies, FDA should use these 
channels to maintain close contact with these stakeholders to ensure that it receives 
direct information about emergency testing.  In May 2022, FDA entered into a
memorandum of understanding (MOU) with CDC and lab stakeholders (including 
APHL and ACLA).99  We urge FDA to use this MOU  as a starting point in building a 
collaborative relationship with CDC and the lab community before the next 
emergency.  
Work with Federal partners to implement lessons learned about 
a national testing strategy outside the EUA process 
Early challenges with CDCs test rollout, clinical sample shortages, and an 
overwhelming workload shaped FDAs COVID-19 response.  FDA should work closely 
with Federal partners to assess what they can do now to avoid similar challenges in 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing 
OEI-01-20-00380  Conclusion and Recommendations | 30   
the future. This may be done by convening a formal panel of experts from each 
agency involved in emergency response preparations, or developing individual 
partnerships with one or more agencies to address specific challenges.  At a 
minimum, FDA should coordinate with appropriate Federal partners to: 
   Determine the feasibility of contracting with test manufacturers in advance of 
the next emergency. This would ensure that qualified manufacturers are on 
standby and could quickly produce well-designed, high-throughput tests at a 
volume appropriate to meet the needs of each emergency.  It would also 
address manufacturers hesitancy early in the pandemic to invest in a test for a 
novel disease, particularly without government incentives.  Furthermore, it may
circumvent testing delays in case one test or manufacturer encounters 
problems. FDA could seek a partnership with BARDA, which supports the 
development of diagnostic tests during emergencies, to accomplish this. 
   Determine the feasibility of establishing a program to conduct all test 
validation to support EUAs during an emergency.  Rather than requiring each
developer to access its own validation materials, which may be limited early in 
an emergency, the Federal government could develop a program to conduct 
all validation during emergencies.  Validation could occur on one or more 
sites, potentially with Federal partners.  FDA could help expand existing
partnerships with Federal agencies, such as NIH and CDC, that are currently 
assessing COVID-19 serology and over-the-counter tests.  FDA uses data 
provided by these partners to inform its regulatory decisions.  Such an 
approach may also help address problems with developer validation.  
   Determine the feasibility of precertifying labs for emergency test development 
and use. FDA should consider a pre-emergency, nationwide effort to certify 
labs that are qualified to conduct emergency testing for emerging infectious 
diseases. Certified labs would not need to submit an EUA request for tests 
developed and used within that lab to respond to an emergency.  Without so 
many EUAs to review, FDA could devote more resources to supporting less 
experienced test developers.  Certified developers could begin using validated 
tests immediately. FDA could seek a partnership with the Centers for 
Medicare & Medicaid Services (CMS) to accomplish this, as CMS would have 
insight into laboratory qualifications given its oversight role. 
On the basis of its findings for the assessments recommended above, FDA should 
implement all feasible recommendations. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing     
OEI-01-20-00380  Conclusion and Recommendations | 31    
 AGENCY COMMENTS AND OIG RESPONSE 
FDA concurred with all six of our recommendations, as detailed below.   
First, FDA concurred with our recommendation to assess and, as appropriate, revise 
FDA guidance for test EUA submissions.  We acknowledge that FDA has adapted its 
regulatory approach to address the publics testing needs throughout the COVID-19 
pandemic. Given the importance of robust testing, especially in the early stages of a 
pandemic, adapting lessons learned from this pandemic related to developer 
notification and prioritization policies would position FDA to respond to current and 
future pandemics. We appreciate FDAs efforts thus far and look forward to the 
updates on the status of its assessment and revisions, if appropriate, to guidance in its 
Final Management Decision. 
In concurring with our recommendation to develop a suite of EUA templates for 
future emergencies involving novel pathogens, FDA stated that its COVID-19 
templates helped facilitate important conversations with test developers.  FDA also  
reported that it has plans to engage test developers to create generic templates for 
commonly anticipated pathogens. Having general templates on hand and ready for 
the next novel pathogen can speed the EUA process and make it more efficient.  In its 
Final Management Decision, FDA should include an update on the status of the 
templates. 
FDA also concurred with our recommendation to expand CDRHs existing device-
tracking platform to facilitate EUA submission and monitoring.  We acknowledge
FDAs efforts thus far to improve the EUA request process; adding tracking 
functionality would streamline the process and add transparency for stakeholders.  
Improving transparency, reducing duplicative efforts, and making the EUA submission 
process more efficient will help ensure that tests are available for use faster when the 
next novel pathogen emerges. FDA should detail in its Final Management Decision 
the steps it has taken to add EUA requests to its submission tracker tool.  
Next, FDA concurred with our recommendation to expand and improve resources for 
test developers on the EUA process.  In this report, we recommend that FDA continue 
the communication strategies that were successful during the COVID-19 pandemic, 
and FDA has indeed maintained these strategies.  We look forward to FDA updates in 
its Final Management Decision on its progress to expand and improve resources for 
test developers, including technical guidance and educational material  on the EUA 
process.  
FDA concurred with our recommendation to establish formal communication 
channels between FDA and the lab community, to be used in emergencies that 
require testing. In this report, we urged FDA to use the MOU that it entered into with 
CDC and laboratory stakeholders as a starting point to build a collaborative 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing     
OEI-01-20-00380  Agency Comments and OIG Response | 32    
relationship with them and the lab community.  FDA has already started to engage via 
this MOU for its response to monkeypox. Continuing to build and strengthen
channels with the lab community will ensure that FDA maintains close contact with 
lab community stakeholders during current and future emergencies that require 
testing. We appreciate FDAs efforts thus far and look forward to further updates on 
the status of its efforts to establish these channels in its Final Management Decision. 
Finally, FDA concurred with our recommendation to work with Federal partners to 
implement lessons learned about a national testing strategy outside the EUA process.  
We acknowledge that FDA has already communicated lessons learned through a 
variety of avenues.  We ask that FDA describe the steps that it is taking, which may 
include convening a formal panel or developing individual partnerships, among other 
potential approaches in its Final Management Decision. 
For the full text of FDAs comments, see the Appendix that follows this section. 
 
 
 
 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing     
OEI-01-20-00380  Agency Comments and OIG Response | 33    
APPENDIX 
Appendix: Agency Comments   
Following this page are the official comments from FDA.    
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing     
OEI-01-20-00380  Appendix | 34    FDAs General Comments on  on the  OIG  Draft Report, FDA Repeatedly 
 Adapted Emergency Use Authorization Policies  to Address the Need for  COVID-19 Testing 
 
 
FDA appreciates the opportunity from the  HHS Office of the Inspector General  to 
review and comment on this draft report.  
 
General Comments  
 
Recommendation  1  
 
FDA should assess  and, as appropriate, revise guidance for test EUA submissions.  
 
FDA  Response  
 
FDA concurs  that it should  assess and, as appropriate, revise guidance  for test EUA  
submissions  as the circumstances of  PHEs warrant.   Since the start of the COVID pandemic,  
FDA adapted its regulatory approach to address the publics testing needs, taking into 
account benefits and risks of providing additional flexibilities under  the circumstances  at the 
time. FDA continues to work closely with test developers to help them adjust as those needs  
have changed. These efforts have helped  support increased  testing capacity overall  and 
broadened  public access  to rapid tests, including those purchased over the  counter (OTC). In  
addition to at-home diagnostic tests, FDAs flexible policies have supported authorization of  
a myriad of options, including molecular and antigen tests, as well as serology tests; Point-
Of-Care  tests;  home collection tests;  multi-analyte tests that can detect both COVID-19 and 
flu; tests using various sample types, including saliva; and screening tests with pooling and 
serial testing.  FDA made clear its review priorities, which were  updated as appropriate. For  
example,  FDA prioritized  review of  EUA requests  that increased  national testing capacity  
(e.g., for high throughput tests)  or enhanced accessibility  when needs indicated. 
Prioritization for tests allowed FDA to best allocate limited resources, which became critical  
as FDA  faced an ever increasing and unprecedented number of EUA  test  submissions. The 
Agency continues to receive about 100 EUA requests and pre-EUA submissions each month 
for COVID-19 tests.  
 
FDA also  withdrew policies if and when the  circumstances warranted. For  example, when 
clinical specimens became widely available, FDA  updated its policy to recommend  their use 
in validation rather than contrived specimens. When FDA saw many serology tests coming 
to market that did not perform as claimed, including those claiming to diagnose COVID-19, 
the Agency discontinued its policy of no longer objecting to offering serology tests without  
first receiving EUA authorization. 
 
As FDA continues to support the nations response to COVID-19 and future PHEs, the  
Agency will carefully evaluate which policies  are  appropriate to support development of  
accurate and  reliable  tests and update them when  circumstances warrant.  
 
Recommendation 2  
 
FDA should develop a suite of EUA templates for  future emergencies involving novel  
pathogens.  
   
 
FDA Response  
 
FDA concurs  with OIGs recommendation. FDA had also received  a similar  
recommendation from an independent study to develop a framework for how to conduct  
validation of diagnostic tests for emerging pathogens in the setting of a declared PHE. FDA  
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)  tests. FDA has noted these plans publicly here:   Emergency  
Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response  |  
FDA. In  fact, stakeholders have reached out to engage with FDA, and we have received  
helpful feedback  that we have  already incorporated into our validation templates.  
 
COVID-19 templates provided recommendations for test validation and a fill-in-the-blank 
form to streamline the paperwork and make it easier for developers to provide information 
in support of  EUA requests.  Since providing the first template in January 2020, FDA has  
been in daily contact with test developers to answer questions and help them through the  
EUA process. FDA had as many as ten posted templates and continues to update, add, 
combine, and remove templates as the science evolves and as necessary to support COVID-
19 test developers. As of August 8, 2022, these templates have received  over 6039 hits from  
those visiting FDAs website.   
 
FDA notes that its templates provide recommendations based on FDAs experience, the state  
of the science,  availability of validation  material or other components, and the regulatory 
criteria to issue  an EUA.   Our recommendations are just that  recommendations. FDA is  
always open to alternative proposals from developers and will continue to consider those. 
More significant trade-offs in test accuracy may be appropriate where the need for  
availability and fast results is not being met. We found during the COVID-19 pandemic that  
our templates helped to facilitate these important  conversations with developers and believe  
they will be critical in the future when  we are faced  with  pathogens, both well-known and 
novel. 
 
Recommendation  3  
 
FDA should expand the  FDA Center for Devices  and Radiological Healths existing device-
tracking platform to facilitate EUA submission and monitoring.  
 
FDA Response:   
 
FDA concurs with OIGs recommendation and notes that this is also consistent  with a  
recommendation made by an independent study:   Emergency Use Authorization of COVID-
19 Tests: Independent Assessment of the FDAs Response  | FDA. In an effort to provide  
transparency, efficiency, and predictability for test developers, , FDA has implemented  
improvements and streamlined its EUA  review  processes.    From March 2020 to present, 
CDRH has identified  IT  system needs and implemented several improvements to facilitate  
EUA request submission tracking, including updating current systems to improve the  
tracking and management of EUA review and providing electronic submission (vs. mailing)  
capabilities for EUA submissions through our CDRH Submission Portal.  
 
Page 2  of 5    
 
FDA plans to continue  IT improvements that will streamline processes and improve  
transparency for sponsors, including adding EUA  requests and other submissions to its  
submission tracker, though this will ultimately depend on resources.  
 
FDA also notes that CDRH initiated a Digital Transformation  Initiative in Fiscal Year (FY)  
2016, which is ongoing. This initiative focuses 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  are organized, curated properly, and 
accurate for decision making. This ongoing 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.  
. 
Recommendation  4  
 
FDA should expand and improve resources for test developers on the EUA  process.  
 
FDA Response  
 
FDA concurs with OIGs  recommendations.  FDA  had also received  a related  
recommendation from an independent study to develop a framework for how to conduct  
validation of diagnostic tests for emerging pathogens in the setting of a declared PHE.1  2  As  
noted in one of our previous responses, FDA plans to continue strengthening 
communication strategies and tools that have proven 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, and has  
already taken additional  steps to do so. 
 
As OIGs report acknowledges, FDA entered into a memorandum of understanding (MOU) 
with CDC and laboratory stakeholders (including APHL and ACLA) in May 2022, a formal  
step  in further building collaborative relationships  with the lab community. FDA is already  
fully engaged with CDC and developers under this MOU with respect to Monkeypox. 
Specifically, FDA is providing regulatory as well  as clinical and technical  diagnostics  
expertise to facilitate discussions about planning and implementing surge  capacity for  
diagnostic testing. The Agency believes that even in this short time, the MOU has been 
helpful, particularly for allowing the USG to hear  directly from laboratory professional  
associations and large commercial laboratories regarding:  
a.   their willingness to test,   
b.  what they are hearing in their interactions,  
c.   where their pain points are,  
d.  barriers to getting involved in any kind of response, and  
e.   suggestions on next steps from their perspectives  
 
In addition, FDA  continues its regular town hall meetings for COVID-19 test developers and 
has started to include Monkeypox test announcements and updates during these sessions.  
 
 
1  Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response | FDA  
2  Deliverable 15: Emergency Use Authorization Assessment  - Final Report (fda.gov)  
Page 3  of 5    
 
The Agency also planned with CDC and participated in a Laboratory Biosafety Townhall on 
June 24, 2022, which was a collaboration with clinical and public health laboratory partners  
and instrument manufacturers discussing testing in laboratories during emergencies.3   
 
These are just a few steps FDA has taken, in addition to incorporating stakeholder feedback 
into our templates.  
 
Recommendation  5  
 
FDA should establish formal communication channels between  FDA  and the lab  
community, to be used in emergencies that require testing. 
 
FDA Response  
 
FDA concurs with OIGs  recommendations.  FDA  had also received  a related  
recommendation from an independent study to develop a framework for how to conduct  
validation of diagnostic tests for emerging pathogens in the setting of a declared PHE.4  5  As  
noted in one of our previous responses, FDA plans to continue strengthening 
communication strategies and tools that have proven 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, and has  
already taken additional  steps to do so. 
 
As OIGs report acknowledges, FDA entered into a memorandum of understanding (MOU)  
with CDC and laboratory stakeholders (including APHL and ACLA) in May 2022, a formal  
step  in further building collaborative relationships  with the lab community. FDA is already  
fully engaged with CDC and developers under this MOU with respect to Monkeypox. 
Specifically, FDA is providing regulatory as well  as clinical and technical  diagnostics  
expertise to facilitate discussions about planning and implementing surge  capacity for  
diagnostic testing. The Agency believes that even in this short time, the MOU has been 
helpful, particularly for allowing the USG to hear  directly from laboratory professional  
associations and large commercial laboratories regarding:  
a.   their willingness to test,   
b.  what they are hearing in their interactions,  
c.   where their pain points are,  
d.  barriers to getting involved in any kind of response, and  
e.   suggestions on next steps from their perspectives  
 
In addition, FDA  continues its regular town hall  meetings for COVID-19 test developers and 
has started to include Monkeypox test announcements and updates during these sessions.  
 
The Agency also planned with CDC and participated in a Laboratory Biosafety Townhall on 
June 24, 2022, which was a collaboration with clinical and public health laboratory partners  
and instrument manufacturers discussing testing in laboratories during emergencies.6   
 
3  CDC Town Hall Meeting on Laboratory Biosafety - Use of  Laboratory Instruments, June  24, 2022  
4  Emergency Use Authorization of COVID-19 Tests: Independent Assessment of the FDAs Response | FDA  
5  Deliverable 15: Emergency Use Authorization Assessment  - Final Report (fda.gov)  
6  CDC Town Hall Meeting on Laboratory Biosafety - Use of  Laboratory Instruments, June  24, 2022  
Page 4  of 5    
 
 
These are just a few steps FDA has taken, in addition to incorporating stakeholder feedback 
into our templates.  
 
Recommendation  6  
 
FDA should work with Federal partners to implement lessons learned about a national  
testing strategy that go beyond the EUA process.  
 
FDA Response  
 
FDA concurs with OIGs recommendation. We have already communicated lessons learned 
through a variety of  avenues,7  8  9including the publication of  two  peer-reviewed articles  10  11  
and will continue to work with Federal partners to try to implement them. 
 
 
7  Bending The Arc Of COVID-19 Test Development To Increase Access And Ensure Reliability 
Now And In The  Future  | Health Affairs  
8  South Koreas  Implementation Of A COVID-19 National Testing Strategy | Health Affairs  
9  South Korea's Response  to COVID-19: Focus on Testing Strategy and Lessons Learned (fda.gov)  
10  Covid-19 Molecular Diagnostic Testing  Lessons Learned | NEJM  
11  The FDAs Experience  with Covid-19 Antibody Tests | NEJM  
Page 5  of 5    
 
 ACKNOWLEDGMENTS AND CONTACT   
 
Elizabeth Sandefer served as the team leader for this study.  Others in the Office of 
Evaluation and Inspections who conducted the study include Sarah Hijaz and Malaena 
Taylor. Office of Evaluation and Inspections headquarters staff who provided support 
include Althea Hosein and Michael Novello.  
This report was prepared under the direction of Joyce Greenleaf, Regional Inspector 
General for Evaluation and Inspections in the Boston regional office, and Danielle 
Fletcher, Deputy Regional Inspector General.  
Contact 
To obtain additional information concerning this report, contact the Office of Public 
Affairs at Public.Affairs@oig.hhs.gov. OIG reports and other information can be found 
on the OIG website at oig.hhs.gov.  
Office of Inspector General 
U.S. Department of Health and Human Services
330 Independence Avenue, SW 
Washington, DC 20201  
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Acknowledgements and Contact | 40    
ABOUT THE OFFICE OF INSPECTOR GENERAL 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 
95-452, as amended, is to protect the integrity of the Department of Health and 
Human Services (HHS) programs, as well as the health and welfare of beneficiaries 
served by those programs.  This statutory mission is carried out through a nationwide 
network of audits, investigations, and  inspections conducted by the following 
operating components: 
The Office of Audit Services (OAS)  provides auditing services for HHS, 
either by conducting audits with its own audit resources or by overseeing audit work 
done by others. Audits examine the performance of HHS programs and/or its 
grantees and contractors in carrying out their respective responsibilities and are 
intended to provide independent assessments of HHS programs and operations.  
These audits help reduce waste, abuse, and mismanagement and promote economy 
and efficiency throughout HHS. 
The Office of Evaluation and Inspections (OEI)  conducts national 
evaluations to provide HHS, Congress, and the public with timely, useful, and reliable 
information on significant issues.  These evaluations focus on preventing fraud, waste, 
or abuse and promoting economy, efficiency, and effectiveness of departmental 
programs. To promote impact, OEI reports also present practical recommendations 
for improving program operations. 
The Office of Investigations (OI)  conducts criminal, civil, and administrative 
investigations of fraud and misconduct related to HHS programs, operations, and 
beneficiaries. With investigators working in all 50 States and the District of Columbia, 
OI utilizes its resources by actively coordinating with the Department of Justice and 
other Federal, State, and local law enforcement authorities.  The investigative efforts
of OI often lead to criminal convictions, administrative sanctions, and/or civil 
monetary penalties. 
The Office of Counsel to the Inspector General (OCIG) provides 
general legal services to OIG, rendering advice and opinions on HHS programs and 
operations and providing all legal support for OIGs internal operations.  OCIG 
represents OIG in all civil and administrative fraud and abuse cases involving HHS 
programs, including False Claims Act, program exclusion, and civil monetary penalty 
cases. In connection with these cases, OCIG also negotiates and monitors corporate 
integrity agreements. OCIG renders advisory opinions, issues compliance program 
guidance, publishes fraud alerts, and provides other guidance to the health care 
industry concerning the anti-kickback statute and other OIG enforcement authorities. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  About the Office of Inspector General | 41    
ENDNOTES 
 
1 The virus that causes COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).  For readability, this 
report will refer to both the illness and the virus as COVID-19. 
2 Michelle L. Holshue, Chas BeBolt, Scott Lindquist, Kathy H. Lofy, John Wiesman, Hollianne Bruce, Christopher Spitters, et al.,  
First Case of 2019 Novel Coronavirus in the United States, New England Journal of Medicine, March 5, 2020, 382: 929-936.  
3 Although WHO did not declare COVID-19 a pandemic until March, for readability, this report will refer to the entire time  
period after COVID-19 emerged as the COVID-19 pandemic or the pandemic. 
4 World Health Organization,  Timeline: WHOs COVID-19 response.   Accessed at 
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline# on April 11, 2022. 
5 CDC, Principles of Epidemiology in Public Health Practice. Accessed at 
https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section11.html on October 4, 2021. 
6 CDC, COVID Data Tracker. Accessed at https://covid.cdc.gov/covid-data-tracker/#datatracker-home on May 25, 2022. 
7 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical 
Laboratories, Commercial Manufacturers, and Food and  Drug Administration Staff,  May 11, 2020.  Accessed at 
https://www.fda.gov/media/135659/download on September 21, 2021. 
8 The World Health Organization first dispatched a diagnostic test for COVID-19 to its Regional Offices on February 2, 2020. 
World Health Organization,  Timeline: WHOs COVID-19 response.  Accessed at 
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/interactive-timeline#event-46 on February 16, 2022.  
9 FDA, FDA Announced Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures, January 27, 2020.  
Accessed at https://www.fda.gov/news-events/press-announcements/fda-announces-key-actions-advance-development-
novel-coronavirus-medical-countermeasures on September 21, 2021.  
10 21 U.S.C.  360bbb-3.
11 21 CFR  860.7.  
12 FDA, FAQs on Emergency Use Authorizations (EUAs) for Medical Devices During the COVID-19 Pandemic.   Accessed at 
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-
devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic on December 22, 2021. 
13 The Secretary may also declare that circumstances exist to justify EUA for certain products based on significant potential of 
an emergency, without the declaration of a public health emergency.  For the purposes of this report, we will use the term  
emergency to include public health emergencies.  
14 21 U.S.C.  360bbb-3.
15 FDA, Emergency Use Authorization.  Accessed at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization on March 20, 2020. 
16 Federal Register,  Determination of Public Health Emergency, February 7, 2020. Accessed at 
https://www.federalregister.gov/documents/2020/02/07/2020-02496/determination-of-public-health-emergency on April 11,
2022. 
17 21 U.S.C.  360bbb-3.
18 FDA, Emergency Use Authorization.  Accessed at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization on March 20, 2020. 
19 Test developers may request FDA approval or clearance to market and use their product.  Test developers may seek approval 
or clearance during emergencies or nonemergencies.  
20 21 CFR  860.7.  
21 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical 
Laboratories, Commercial Manufacturers, and Food and  Drug Administration Staff, May 11, 2020.  Accessed at 
https://www.fda.gov/media/135659/download?fbclid=IwAR3QjmFqN2BMNJq4IFCfDOnpogvsdsJdwM4pJFE1E1ltqNNRJ8zBjFUS 
OSQ on October 5, 2021. 
22 FDA, Emergency Use Authorization of Medical Products  and Related Authorities, January 2017.  Accessed at Emergency Use 
Authorization of Medical Products (fda.gov) on September 21, 2021. 
23 21 U.S.C.  360bbb-3. 
 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Endnotes | 42    
 
24 21 CFR  860.7.  
25 FDA, Emergency Use Authorization of Medical Products  and Related Authorities: Guidance for Industry and Other Stakeholders, 
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022. 
26 Jeffrey Shuren, FDAs Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability. 
Accessed at https://www.fda.gov/news-events/fda-voices/fdas-ongoing-work-support-and-advance-covid-19-diagnostic-test-
accuracy-and-availability on September 23, 2021. 
27 Project BioShield Act of 2004, P.L. 108-276 July 21, 2004. 
28 FDA, Emergency Use Authorizations for Medical Devices.  Accessed at https://www.fda.gov/medical-devices/emergency-
situations-medical-devices/emergency-use-authorizations-medical-devices#coronavirus2013 on July 9, 2020. 
29 The Medical Device Amendments of 1976, P.L. 94-295, are codified largely in ch. V of the FFDCA,  501573, 21 U.S.C. 
351360ccc-2. 
30 FDA, How to Determine If Your Product Is a Medical Device.   Accessed at https://www.fda.gov/medical-devices/classify-your-
medical-device/how-determine-if-your-product-medical-device on September 29, 2021. 
31 FDA, Center for Devices and Radiological Health.  Accessed at https://www.fda.gov/about-fda/fda-organization/center-
devices-and-radiological-health on June 13, 2022. 
32 21 U.S.C.  360bbb-3.
33 FDA, FDA Virtual Town Hall Series- Immediately in Effect  Guidance on Coronavirus (COVID-19) Diagnostic Tests,  September 
23, 2020. Accessed at https://www.fda.gov/media/142511/download on October 7, 2021. 
34FDA, How to Submit a Pre-Emergency Use Authorization for In vitro Diagnostics to FDA. Accessed at 
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/how-submit-pre-
eua-vitro-diagnostics-fda on July 6, 2020. 
35 FDA, Emergency Use Authorization of Medical Products  and Related Authorities: Guidance for Industry and Other Stakeholders, 
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022. 
36 FDA, Emergency Use Authorization of Medical Products  and Related Authorities: Guidance for Industry and Other Stakeholders, 
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022. 
37 FDA, Emergency Use Authorization of Medical Products  and Related Authorities: Guidance for Industry and Other Stakeholders, 
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022. 
38 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Developers  and 
Food and  Drug Administration Staff, November 15, 2021.  Accessed at https://www.fda.gov/media/135659/download on May 
27, 2022. 
39 21 U.S.C.  360bbb-3.
40 FDA, Emergency Use Authorization of Medical Products  and Related Authorities: Guidance for Industry and Other Stakeholders, 
January 2017. Accessed at https://www.fda.gov/media/97321/download on July 7, 2020. 
41 21 U.S.C.  360bbb-3.
42 FDA, Emergency Use Authorization of Medical Products  and Related Authorities: Guidance for Industry and Other Stakeholders, 
January 2017. Accessed at https://www.fda.gov/media/97321/download on May 25, 2022. 
43 FDA has also authorized other tests for the medical management of patients with COVID-19, but those are excluded from 
this study.
44 FDA, Important Information on the Use of Serological (Antibody) Tests for COVID-19  Letter to Health Care Providers, April 17,  
2020. Accessed at: https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-
antibody-tests-covid-19-letter-health-care-providers on September 21, 2021. 
45 FDA, Coronavirus (COVID-19) Update: Daily Roundup May 29, 2020, May 29, 2020. Accessed at https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-29-2020 on September 24, 2021. 
46 FDA, FDA Roundup: May 3, 2022.  Accessed at https://www.fda.gov/news-events/press-announcements/fda-roundup-may-3-
2022 on May 3, 2022. 
47 Eighty-four of our 237 respondents developed more than one test for COVID-19, and many of these developers applied for 
EUA for more than one test. To avoid confusion, our survey questions specifically asked about each developers first  
experience applying for EUA for a COVID-19 test. 
48 CDC, Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins,  February 6, 2020.  Accessed at 
https://www.cdc.gov/media/releases/2020/p0206-coronavirus-diagnostic-test-kits.html on December 9, 2021. 
49 Public health labs work with CDC during emergencies to conduct clinical diagnostic testing and disease surveillance, among 
other activities. 
 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Endnotes | 43    
 
50 FDA, Coronavirus (COVID-19) Update: FDA expedited review of diagnostic tests to combat  COVID-19, March 30, 2020.  
Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expedites-review-
diagnostic-tests-combat-covid-19 on October 18, 2021. 
51 Document submitted to the Homeland Security & Governmental Affairs Committee (2021). 
52 Testimony from Robert Redfield to the House Foreign Affairs Subcommiitee on Asia, the Pacific, and Nonproliferation. 
Coronavirus Disease 2019: The U.S. and International Response. Accessed at 
https://www.cdc.gov/washington/testimony/2020/t20200127.htm on March 3, 2022.  
53 Letter to Grace Kubin, Director, Laboratory Services Section, Texas Department of State Health Services, and Scott J. Becker,  
Chief Executive Officer, Association of Public Health Laboratories, from Stephen M. Hahn, Commissioner, FDA, February 26, 
2020. Accessed at https://context-cdn.washingtonpost.com/notes/prod/default/documents/1bbf4d0e-8c11-4126-b3af-
24a0575c0012/note/076de12e-172d-49e5-8c50-883688f9c999. on August 11, 2022. 
54 FDA, Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics, February 29, 2020.
Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-issues-new-policy-help-expedite-availability-diagnostics on December 27, 2021. 
55 FDA subsequently received letters from the New York State Department of Health, the New York City Department of Health 
and Mental Hygiene, the American Association for Clinical  Chemistry, and the American Society for Microbiology, asking FDA
to consider taking steps to allow certain labs to begin testing without EUA. 
56 FDA reduced the number of positive specimens to the smallest number that would still statistically demonstrate acceptable 
test performance.   
57 FDA, Accelerated Emergency Use Authorization Templates for SARS-CoV-2 (COVID-19) Molecular Testing of Respiratory 
Specimens in CLIA Certified High-Complexity Laboratories, March 7, 2020. Accessed at https://asm.org/ASM/media/Article-
Images/EUA-Covid19-Template.pdf on April 11, 2022. 
58 Jeffrey Shuren and Timothy Stenzel, Covid-19 Molecular Diagnostic Testing  Lessons Learned,  The New England Journal of 
Medicine, October 22, 2020, 383: e97. 
59 FDA, Accelerated Emergency Use Authorization Templates for SARS-CoV-2 (COVID-19) Molecular Testing of Respiratory 
Specimens in CLIA Certified High-Complexity Laboratories, March 7, 2020.  Accessed at https://asm.org/ASM/media/Article-
Images/EUA-Covid19-Template.pdf on April 11, 2022. 
60 Jeffrey Shuren and Timothy Stenzel, Covid-19 Molecular Diagnostic Testing  Lessons Learned,  The New England Journal of 
Medicine, October 22, 2020, 383: e97. 
61 FDA, Coronavirus (COVID-19) Update: Daily Roundup,  March 23, 2020.  Accessed at https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-daily-roundup on December 21, 2021. 
62 FDA, Coronavirus (COVID-19) Update: Daily Roundup May 11, 2020, May 11, 2020.  Accessed at https://www.fda.gov/news-
events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-11-2020 on December 27, 2021. 
63 The Coronavirus Aid, Relief, and Economic Security Act requires insurance payers to pay for EUA authorized tests as well as 
tests for which the developer requested or intends to request EUA.  It is unclear why insurance payers did not pay for the 
developers test in this instance. 
64 P.L. 109148. 
65 As of November 2021, eight States and Puerto Rico notified FDA that they are operating under this flexibility.  Labs in these 
States do not need to seek EUA or engage with FDA; thus, we were not able to assess the effect on testing for States that 
accepted this policy. 
66 FDA, Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics, February 29, 2020.
Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-
update-fda-issues-new-policy-help-expedite-availability-diagnostics on December 27, 2021. 
67 FDA, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite  
Availability of Diagnostics, March 16, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help on December 27, 2020. 
68 Anand Shah and Jeffrey Shuren,  Insight into FDAs Revised Policy on Antibody Tests: Prioritizing Access and Accuracy,  May 4, 
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021. 
69 Anand Shah and Jeffrey Shuren,  Insight into FDAs Revised Policy on Antibody Tests: Prioritizing Access and Accuracy,  May 4, 
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021. 
 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Endnotes | 44    
 
70 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594.  
71 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
72 These are labs  certified as high-complexity under the Clinical Laboratory Improvement Amendments (CLIA). 
73 FDA, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite  
Availability of Diagnostics, March 16, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help on December 27, 2020. 
74 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
75 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
76 The Coronavirus Aid, Relief, and Economic Security Act later extended FDAs authority to seek information about potential 
supply shortages.
77 Jeffrey Shuren and Timothy Stenzel, Covid-19 Molecular Diagnostic Testing  Lessons Learned,  The New England Journal of 
Medicine, October 22, 2020, 383: e97. 
78 Jeffrey Shuren and Timothy Stenzel, Covid-19 Molecular Diagnostic Testing  Lessons Learned,  The New England Journal of 
Medicine, October 22, 2020, 383: e97. 
79 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
80 Sheila Kaplan,  FDA Orders Companies to Submit Antibody Test Data, The New York Times,  May 4, 2020.  Accessed at 
https://www.nytimes.com/2020/05/04/health/fda-antibody-tests-
coronavirus.html?utm_campaign=pharmalittle&utm_source=hs_email&utm_medium=email&utm_content=87429 
897&_hsenc=p2ANqtz-9gWqHfGuypBVzNZbMBhjbNBl_qTPV3lwDtk7Y9eXG0l5lbbs4JQW4lfe9Ej-- 
R0foxQzLAPZzhjVyvfXnvHDNNWJi1Bg&_hsmi=87429897 on June 8, 2020. 
81 FDA, Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite  
Availability of Diagnostics, March 16, 2020. Accessed at https://www.fda.gov/news-events/press-announcements/coronavirus-
covid-19-update-fda-provides-more-regulatory-relief-during-outbreak-continues-help on December 27, 2020. 
82 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
83 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
84 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
85 FDA, Important Information on the Use of Serological (Antibody) Tests for COVID-19- Letter to Health Care Providers,  April 17,  
2020. Accessed at https://www.fda.gov/medical-devices/letters-health-care-providers/important-information-use-serological-
antibody-tests-covid-19-letter-health-care-providers on September 24, 2021. 
86 FDA, Coronavirus (COVID-19) Update: Serological Test Validation and Education Efforts,  April 18, 2020.  Accessed at 
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-test-validation-and-
education-efforts on October 21, 2021. 
87 Jeffrey Shuren and Timothy Stenzel, The FDAs Experience  with Covid-19 Antibody Tests, The New England Journal of  
Medicine,  February 18, 2021, 384:592-594. 
88 FDA, EUA Authorized Serology Test Performance.  Accessed at https://www.fda.gov/medical-devices/coronavirus-disease-
2019-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance on October 21, 
2021. 
89 Anand Shah and Jeffrey Shuren,  Insight into FDAs Revised Policy on Antibody Tests: Prioritizing Access and Accuracy,  May 4, 
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021. 
90 Anand Shah and Jeffrey Shuren,  Insight into FDAs Revised Policy on Antibody Tests: Prioritizing Access and Accuracy,  May 4, 
2020. Accessed at https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-
and-accuracy on December 27, 2021. 
 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Endnotes | 45    
 
91 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised), May 4, 2020. Accessed at  
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-
public-health-emergency-revised on October 5, 2021. 
92 FDA, Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2. Accessed at 
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/notifications-and-emergency-use-
authorizations-faqs-testing-sars-cov-2 on October 21, 2021. 
93 FDA, Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests, May 21, 2020.  Accessed at 
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-promised-transparency-
antibody-tests on October 21, 2021.
94 FDA, Import Alerts. Accessed at https://www.fda.gov/industry/actions-enforcement/import-alerts on June 29, 2022. 
95 FDA, Historical Information about Device Emergency Use Authorizations.  Accessed at https://www.fda.gov/medical-
devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations on 
December 27, 2021. 
96 FDA, Coronavirus (COVID-19) Update: January 29, 2021. Accessed at https://www.fda.gov/news-events/press-
announcements/coronavirus-covid-19-update-january-29-2021 on December 27, 2021. 
97 FDA, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised): Guidance for Clinical 
Laboratories, Commercial Manufacturers, and Food and  Drug Administration Staff. Accessed at 
https://www.fda.gov/media/135659/download on September 21, 2021. 
98 FDAs EUA authority includes broad flexibility to set prioritization criteria for reviewing EUA requests. For example, FDA may 
prioritize certain tests for review to meet a public health goal such as maximizing capacity to process tests.  See FDA, 
Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders,  January  
2017. Accessed at https://www.fda.gov/media/97321/download on October 7, 2021. 
99 MOU 225-22-020.  Accessed at https://www.fda.gov/about-fda/domestic-mous/mou-225-22-020 on June 28, 2022. 
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing   
OEI-01-20-00380  Endnotes | 46