U.S. Department of Health and Human Services 
 Office of Inspector General 
 
Issue Brief 
 
 September 2022, OEI-01-20-00381 
 
FDAs Work with the Tri-Agency Task Force for Emergency 
Diagnostics Helped Labs Implement COVID-19 Tests 
Why OIG Did This Review 
Key Results 
In 2019, the Food and Drug Administration (FDA), the Centers for 
FDAs engagement with the task  Disease Control and Prevention (CDC), and the Centers for Medicare 
force demonstrates the value of  & Medicaid Services (CMS) established the Tri-Agency Task Force for 
interagency coordination and 
Emergency Diagnostics (the task force) to enhance the effectiveness 
collaboration to facilitate 
of the Federal response to emergencies that require labs to 
emergency test implementation 
implement tests.  FDA is responsible for regulating in vitro diagnostic 
in labs.  FDAs continued 
tests for infectious diseases (hereinafter referred to as tests), 
participation holds further 
including authorizing them for use, in a public health emergency.  
potential for improved responses 
After a test is authorized, FDA, CDC, and CMS have distinct 
in the future. 
responsibilities to ensure that labs appropriately implement, or use, 
tests.  However, multiple setbacks plagued the early testing rollout for COVID-19, which was the first 
emergency since the task force was established.  In the context of this failure, this study focused on 
whether FDAs engagement with the task force helped labs appropriately implement COVID-19 tests. 
How OIG Did This Review 
We focused our review on the task forces activities from its establishment in February 2019 through 
October 2020.  We reviewed task force documents, including meeting minutes, for insight into task 
force activities and to determine how FDA worked with task force members to prepare for future 
emergencies and respond to COVID-19.  We also interviewed eight FDA staff members. 
What OIG Found 
Prior to the COVID-19 pandemic, FDA worked with the task force to identify gaps in responses to prior 
emergencies (e.g., the Zika virus outbreak).  The task force made two recommendations within FDAs 
jurisdiction: (1) require test manufacturers to include certain information with tests, and (2) require test 
manufacturers to provide test verification materials with tests.  FDA implemented both 
recommendations during the COVID-19 pandemic and reported that these were helpful for labs.   
Starting in January 2020, the task force pivoted to respond to the COVID-19 pandemic.  FDA found the 
task force meetings served as opportunities to collaborate, coordinate, and communicate across 
member agencies.  It worked with task force members on drafting written products, troubleshooting, 
and solving problems.  FDA members found that participating in the task force fostered relationships 
that were beneficial both within the task forces scope and beyond it. 
Conclusion 
The task force experience demonstrates the importance and potential benefits of expanding 
interagency exchanges, including for those parts of the testing process that struggled during the 
pandemic.  Indeed, FDAs continued coordination with the task force holds potential for further 
improvements in emergency test implementation in labs.   
BACKGROUND 
 
 
OBJECTIVE 
To determine the extent to which Food and Drug Administration (FDA) engagement with the 
Tri-Agency Task Force for Emergency Diagnostics helped facilitate laboratories ability to 
implement COVID-19 tests. 
 
The COVID-19 pandemic challenged our Nations ability to mobilize a robust testing 
response to an emerging infectious disease.  Testing is a key first step in responding 
to any infectious disease outbreak because it helps to identify cases and contain the 
spread of disease.  When a public health emergency is caused by a novel pathogen, 
such as with COVID-19, the response is especially complex because typically no in 
vitro diagnostic test (hereinafter referred to as test) for a novel infectious disease 
exists.1  Developers must quickly create tests and request authorization to use and 
manufacture their tests.  FDA is responsible for regulating tests, including authorizing 
them for use, in a public health emergency.2, 3  However, after authorizing a test, FDA 
works with the Centers for Disease Control and Prevention (CDC) and the Centers for 
Medicare & Medicaid Services (CMS) to ensure that labs implement, or use, tests 
appropriately.4  Furthermore, no single Federal entity oversees the many public and 
private stakeholders involved in emergency testing.   
The setbacks to COVID-19 testing in early 2020 illustrate the failed rollout of testing in 
the U.S.5  In February 2020, FDA authorized CDCs COVID-19 test, making it the first 
and only in the nation.  However, CDCs test was problematic and for weeks only a 
small number of labs were able to use it.  The resulting void in testing came at a 
crucial moment in the pandemic response, as no other test was available to fill the 
gap.  Other challenges, including limited access to materials required to demonstrate 
that tests work as intended and other supply shortages, further impeded the testing 
rollout. 
Amidst the overall testing failure, FDA worked with CDC and CMS as part of the Tri-
Agency Task Force for Emergency Diagnostics (hereinafter, the task force) to facilitate 
the appropriate implementation of tests authorized for emergency use in labs.  
Established in response to lessons learned from prior infectious disease outbreaks, the 
task force leverages each agencys unique expertise to ensure that labs implement 
emergency tests appropriately and effectively.  FDAs engagement with that task force 
is the subject of this report. 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Background | 1  FDAs emergency use authorization for tests during a public 
health emergency 
FDA is responsible for regulating tests, including authorizing them for use, in a public 
health emergency.6, 7  FDA may issue emergency use authorizations (EUAs) to allow 
test developers to clinically use and market their tests when there are no adequate, 
approved, and available alternatives.8, 9, 10  To request EUA, developers must submit 
data to FDA to demonstrate that their test performs as intended.  However, an EUA 
allows for a more relaxed evidentiary standard (reasonable belief that the product 
may be effective) than is required for medical products that FDA approves or clears 
in nonemergency circumstances (reasonable assurance of safety and 
effectiveness).11, 12, 13  This enables FDA to review and authorize products more 
quickly than in nonemergency circumstances.14  After FDA authorizes a test, labs must 
use this test exactly as specified within the EUA.15   
Because EUA tests do not undergo the same level of review, FDA establishes 
conditions of authorization (COAs) as necessary to protect the publics health.16, 17  
FDA requires stakeholders, including developers, distributors, and labs (as applicable), 
to meet COAs for as long as the EUA is in effect.  Some COAs are required by law, and 
FDA may apply others at its discretion.18  FDA outlines the COAs that each 
stakeholder must meet.  COAs for labs include providing relevant information to 
health care providers with test results, ensuring that lab staff are appropriately 
trained, and collecting information on test performance, among others.  For example, 
labs must report suspected false positive or false negative test results to FDA.19 
FDA, CDC, and CMS roles in emergency testing 
FDA regulates and monitors the tests it authorizes.  FDA requires that developers and 
labs report performance concerns for each test, including false positives and 
negatives.  Health care providers and patients also may report problems with tests to 
FDA.20  CMS and CDC may report performance concerns that they hear from labs to 
FDA.  As appropriate, FDA may work with a developer to modify an EUA or revoke a 
tests EUA.21, 22 
CDC provides subject matter expertise for the emergency testing process, which may 
include expertise on the nature and epidemiology of the disease.23  It establishes 
testing guidance for labs, such as how to determine a positive test result, and may 
advise FDA and CMS on testing.  CDC is also responsible for developing and seeking 
EUA for its own diagnostic test if one is not otherwise available (as was the case for 
COVID-19).  CDC labs and CDC partners use CDCs test.24 
CMS regulates all nonresearch labs that conduct clinical tests.25, 26  Labs must adhere 
to regulations set forth in the Clinical Laboratory Improvement Amendments of 1988 
(CLIA), which establishes quality standards for labs.27, 28  To perform testing, labs must 
obtain certification from CMS.29  CMS surveyors assess labs compliance with CLIA 
quality standards, including having qualified staff and following quality control 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Background | 2  procedures.30  FDA categorizes all lab tests by level of complexity.31  CMS permits 
a lab to use an EUA test only if the lab meets complexity requirements for that test.32 
In their emergency response roles, FDA, CDC, and CMS have distinct but interrelated 
responsibilities to ensure that labs appropriately implement tests during a public 
health emergency (see Exhibit 1).  Labs implement tests by using them as authorized 
by FDA and according to CLIA standards.  Test implementation excludes developing, 
manufacturing, and distributing tests. 
Exhibit 1. FDA, CDC, and CMS work together to ensure that labs appropriately 
implement tests. 
 
The Tri-Agency Task Force for Emergency Diagnostics 
Because of the interrelated nature of their responsibilities, close coordination among 
CDC, CMS, and FDA during a pandemic is critical.  These three agencies created the 
task force to enhance the effectiveness of the Federal response to emergencies that 
require tests.33  The task force aims to prepare for future emergencies so that the 
agencies are better positioned to facilitate implementing tests in labs and can 
efficiently manage their overlapping responsibilities.  During an emergency, the task 
force also aims to serve as a forum for agencies to coordinate and collaborate on 
their responses.34 
FDA, CDC, and CMS launched the task force in 2019.35  The task force charter clarifies 
agencies roles during an emergency response and outlines how agencies should 
collaborate and establish efficient communication channels to share information.  
CDC serves as the task force chair and is responsible for activating the task force, 
facilitating meetings, tracking action items, communicating task force activities with 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Background | 3  external partners, and developing agendas.  Agencies provide representatives to each 
task force meeting, which can also include subject matter experts as appropriate. 
Prior to public health emergencies, members meet biannually to prepare for future 
emergencies.  Based on task force activities, including reviews of prior emergency 
responses, the task force may make recommendations for improvement to itself and 
to member agencies.  The task forces recommendations are based on consensus and 
made with deference to agency statutory authority and areas of expertise. 
The task force convenes at the beginning of an emergency that requires testing (see 
Exhibit 2).  These meetings provide a forum for members to work together to facilitate 
rapid test implementation during that emergency, which may include suggesting 
advice and guidance for labs and other stakeholders. 
Exhibit 2. After authorizing tests during a public health emergency, FDA works 
with task force members to facilitate test implementation in labs. 
 
 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Background | 4  RESULTS 
During COVID-19, FDA made process improvements 
recommended by the task force 
Reflecting on the Ebola and 
Zika virus epidemics, the task  It really all stemmed from Zika and realizing 
force noted gaps in  that once FDA issued an EUA, its not the final 
implementing tests in labs.   step... to having it actually being implemented 
The task force charter requires  in the laboratory.  And so the task force was 
that the task force identify  formed to try and address some of the 
gaps to improve labs  apparent gaps in... once the EUAs been issued, 
efficiency and effectiveness in  how it actually gets implemented into a 
implementing tests.  The task  laboratory.  FDA staff member 
force made recommendations, 
some to itself and some to the   
individual agencies, to address 
each gap.  Each agency decides whether to act on recommendations that fall solely 
within its scope.36   
The task force made several recommendations to itself, and has yet to finish 
implementing them.  One of those recommendations involved developing 
interagency workflows to clarify each agencys role in facilitating test implementation 
in labs.  Another focused on creating universal fact sheets to help providers and 
patients interpret lab test results.  Task force members were working on products to 
respond to these recommendations when COVID-19 emerged. 
Among other actionable gaps the task force identified, two are solely within FDAs 
jurisdiction and FDA implemented corrective actions during the pandemic: 
  Labs lack of understanding on how to meet EUA requirements.  In prior outbreaks, 
FDA posted tests COAs on its website but did not distribute them separately to 
labs, which potentially made them more difficult to access.  The task force 
recommended requiring test manufacturers to include COAs in package inserts 
with tests, which the task force hoped would reduce confusion among lab staff 
implementing tests as well as CMS surveyors.  During the COVID-19 pandemic, 
FDA began requiring this for all EUAs granted for COVID-19 tests.  Several FDA 
task force members noted that this clarified test implementation responsibilities 
for labs.  One member noted that the inclusion of the conditions of authorization 
clearly helped [labs] to quickly understand what they are, what their 
responsibilities have been, and [enabled] them to be up and running faster. 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Results | 5    Labs limited access to control material early in an outbreak.  Labs require control 
material, such as clinical samples of the virus, to make sure that tests work before 
using them.  This process is called verifying a test, and verifying tests is a CLIA 
requirement for labs.  Early in an outbreak, clinical sample shortages are a 
common challenge when infection rates are low.  The task force proposed that 
FDA modify COAs by requiring test manufacturers to include control material for 
verifying tests in their test kits to avoid labs having to source the materials 
themselves, which would take longer.  When COVID-19 emerged, the task force 
also discussed what other kinds of control material would be acceptable to verify 
tests until clinical samples became more available.  Where appropriate, FDA had 
test manufacturers provide control material with their authorized COVID-19 tests 
so that labs could verify them.  FDA task force members stated that carrying out 
this recommendation was a success; labs were able to immediately begin 
implementing tests.. 
FDA found the task force useful for collaborating and 
communicating among its member agencies about 
implementing tests in labs when COVID-19 emerged 
FDA reported that task force meetings provided opportunities to collaborate, 
coordinate, and communicate the efforts underway within member agencies and 
jurisdictions.  On January 15, 2020, the task force held its first COVID-19 response 
meeting.  After this initial meeting, task force meetings generally took place every 
week.  (They became biweekly in October 2020.)  FDA used task force meetings to 
hear other members updates and to brief members on key developments with test 
authorizations.  For example, at the second task force meeting that year, FDA briefed 
the task force on CDCs work requesting an EUA for its test.  FDA also updated 
members on topics including EUA policy changes and the level of interest from 
developers to seek EUA.   
Task force meetings served as opportunities for FDA to collaborate with other 
members.  For example, FDA collaborated within the task force on written products to 
support labs implementing COVID-19 tests (see Exhibit 3).  As appropriate, task force 
members coordinated to ensure that information released by the agencies was 
consistent.  Members also worked to make sure that disseminated information was 
clear and understandable to labs as well as other stakeholders, such as CMS 
surveyors.  In addition, FDA collaborated with CMS and CDC on COVID-19 EUA 
language to ensure that labs can meet FDA requirements without violating CLIA 
regulations.  For example, when FDA began authorizing at-home tests, working with 
CMS and CDC helped ensure that FDAs authorization language would apply to both 
home users and labs. 
 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Results | 6   
Exhibit 3. Examples of written products that FDA worked on with the task force 
during the COVID-19 pandemic 
 
FDA also collaborated with the task force to solve problems that arose during the 
pandemic (see Exhibit 4).  During task force meetings, FDA discussed challenges and 
FDAs progress towards addressing them.  Members from CMS and CDC sometimes 
offered advice for FDA to consider.  For example, FDA noted confusion in the 
academic and clinical communities about whether tests used for disease surveillance 
required EUA, which they did not.  Task force members discussed not only how to use 
non-EUA tests for surveillance but also how to communicate that to stakeholders.  In 
addition, CMS and CDC, which both interact more closely with labs than FDA does, 
often shared information that they heard.  This information included reports about 
potential performance concerns, fraudulent behavior, and problems with 
implementing tests.  For example, during a task force meeting, CDC informed FDA 
that some serology test manufacturers were improperly selling lab tests to nonlabs.  
CDC told FDA that it would provide FDA with the names of the manufacturers.  FDA 
noted that it would issue warning letters if needed to respond to this fraudulent 
behavior. 
Exhibit 4. Examples of troubleshooting and problem solving between FDA and 
other task force members during the COVID-19 pandemic 
 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Results | 7  Agency members also took advantage of one anothers expertise and capabilities 
both during and outside of task force meetings.  For example, FDA benefited from 
CDCs experience with virus mutations as well as from CMSs familiarity with how to 
convey information in language that lab staff and CMS surveyors would understand.  
Task force members could also benefit from agency-specific tools to support other 
agency efforts.  For example, after FDA informed the task force of serology tests that 
no longer met EUA requirements, CDC sent out a message using its own Lab 
Outreach Communication System to alert labs not to use these tests. 
FDAs task force members reported fostering relationships with key experts in CDC 
and CMS through the task force.  Several FDA task force members whom we 
interviewed said that they particularly benefited from information sharing among task 
force members.  One member 
described this information sharing 
as the real value of the task force.  
[The task force] allows us to have points of 
It allowed members to develop a 
contact, so we have unusual questions we can 
deeper understanding of their 
reach out within the agency, and if the task 
respective areas of expertise.  For 
force doesn't know the answer directly, they 
example, task force members held 
can, you know give us or set up a meeting 
separate calls to discuss specific 
with the appropriate subject matter expert to 
topics in more depth.  FDA 
address those questions.  FDA staff member 
members reported that 
connections they made with 
 
colleagues on the task force from 
CDC and CMS helped them solve problems between meetings and outside the task 
forces scope.  They mentioned that they were comfortable reaching out to task force 
members in other agencies, including when they had a question or problem unrelated 
to the task forces primary functions.  
 
 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Results | 8   
CONCLUSION 
 
 
As FDA carried out its responsibilities during the first months of the COVID-19 
pandemic, the task force served as a forum for FDA to collaborate and coordinate 
with CDC and CMS to facilitate emergency test implementation in labs.  Not only did 
the task forces preparatory work identify gaps to address for future emergencies, but 
from day one of the COVID-19 emergency, the task force provided a venue for 
member agencies to coordinate their responses to challenges that arose during the 
pandemic.  Indeed, task force members took advantage of connections made to 
address issues in their response to COVID-19 that went beyond the task forces scope.   
This experience underscores the value of interagency exchanges and highlights the 
importance of building collaborative relationships in advance of an emergency.  
Establishing forums that allow collaboration, and maintaining them in nonemergency 
times, enables the Federal government to more nimbly respond when emergencies 
happen.  Emerging infectious diseases like COVID-19 will always pose challenges 
broader than any single government agency can address alone.  For this reason, 
interagency collaboration will remain important.  
In our report on FDAs EUA process, FDA Repeatedly Adapted Emergency Use 
Authorization Policies to Address the Need for COVID-19 Testing (OEI-01-20-00380), 
we recommended a broader collaboration with Federal partners, including CDC.  This 
would allow FDA and other Federal partners to consider more holistic improvements 
to this countrys approach to rapidly creating, authorizing, manufacturing, and 
deploying tests during emergencies.37  Additionally, as part of OIGs Top Management 
Challenges for HHS, OIG recommends that HHS programs collaborate effectively with 
one another and with other Federal agencies.38 
FDAs continued membership in the task force holds potential for further 
improvements in emergency test implementation in labs.  Maintaining the 
momentum gained during COVID-19 is vital to building the tools, structures, and 
relationships necessary to address current challenges and prepare for the next 
emergency before it strikes. 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Conclusion | 9   
METHODOLOGY 
 
 
Scope 
This inspection examines FDAs work with the task force from the task forces 
establishment in February 2019 through October 2020.  We relied on the following 
sources: (1) task force documents such as the task forces charter, meeting minutes, 
and fact sheets; and (2) interviews with eight FDA staff members.  We did not 
interview staff members from either of the other two agencies that participate in the 
task force, CDC and CMS.   
Data Sources and Analysis  
Documents.  FDA and CDC (the task force chair) provided the following task force 
documents: the task force charter, meeting minutes, newsletter, press releases, 
information sheets, fact sheets, and presentation slides.  FDA also provided us with 
drafts of EUA process workflows.  We spoke with CDC to ensure that we received all 
documents pertaining to the task force.  We then analyzed these documents to 
identify task force activities before and during the pandemic.   
Interviews.  We interviewed eight FDA staff members involved with the task force.  
Interview topics included how they participate and communicate within the task force, 
the extent to which they implemented task force recommendations, and challenges 
that they experienced in working with the task force.  We analyzed these interviews to 
identify themes. 
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. 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Methodology | 10   
ACKNOWLEDGMENTS AND CONTACT 
   
  Acknowledgments 
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 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Acknowledgments and Contact | 11   
EENNDDNNOOTTEESS  
 
  
1 In vitro diagnostic tests are tests done on patient samples, such as blood or saliva, to indicate if a patient has a disease or 
antibodies produced in response to that disease.  All COVID-19 tests are in vitro diagnostic tests.   
2 21 U.S.C.  360bbb-3. 
3 Charter: Tri-Agency Task Force for Emergency Diagnostics.  Accessed at https://www.fda.gov/media/120328/download on 
April 21, 2022. 
  
4 Ibid. 
5 We discuss U.S. testing challenges from January through May 2020 in our companion report, FDA Repeatedly Adapted 
E  mergency Use Authorization Policies to Address the Need for COVID-19 Testing (OEI-01-20-00380). 
6 21 U.S.C.  360bbb-3. 
7 Charter: Tri-Agency Task Force for Emergency Diagnostics.  Accessed at https://www.fda.gov/media/120328/download on 
A  pril 21, 2022. 
8 21 U.S.C.  360bbb-3. 
9 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 March 22, 2022. 
10 The Secretary of Health and Human Services must declare that a public health emergency has significant potential to affect 
national security and, on the basis of this determination, declare that circumstances exist to justify that certain products be 
authorized for emergency use in order for FDA to begin issuing EUAs.  EUA for a product expires at the end of the public 
health emergency, or sooner if FDA revokes the authorization.   
11 21 CFR  860.7. 
12 21 U.S.C.  360bbb-3. 
13 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 March 22, 2022. 
14 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. 
15 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 March 22, 2022. 
16 Ibid. 
17 Charter: Tri-Agency Task Force for Emergency Diagnostics.  Accessed at https://www.fda.gov/media/120328/download on 
March 22, 2022. 
18 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 March 22, 2022. 
19 Ibid. 
20 FDA, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19 Related 
Guidance Documents, July 15, 2021.  Accessed at https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-
devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua-or-discussed-covid-19 on March 
24, 2022. 
21 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 March 22, 2022. 
22 Charter: Tri-Agency Task Force for Emergency Diagnostics.  Accessed at https://www.fda.gov/media/120328/download on 
April 21, 2022. 
23 Ibid. 
24 Ibid. 
25 CMS, Clinical Laboratory Improvement Amendments (CLIA).  Accessed at https://www.cms.gov/Regulations-and-
Guidance/Legislation/CLIA on April 21, 2022. 
26 CMS, Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency Updated as of 12/17/2020.  
Accessed at https://edit.cms.gov/files/document/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-
updated-12-17-2020.pdf on April 21, 2022. 
 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Endnotes | 12   
27 42 CFR  493. 
28 HHS, Quality, Safety, & Oversight- General Information- CLIA (originally issued by CMS on March 5, 2012), December 31, 
2020.  Accessed at https://www.hhs.gov/guidance/document/quality-safety-oversight-general-information-
clia#:~:text=Congress%20passed%20the%20Clinical%20Laboratory,where%20the%20test%20was%20performed on March 24, 
2022.  
29 FDA, Clinical Laboratory Improvement Amendments (CLIA), September 13, 2021.  Accessed at https://www.fda.gov/medical-
devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia on March 24, 2022. 
30 CMS, State Operations Manual Appendix C- Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory 
Services, Rev. 166, 2-03-17.  Accessed at https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/Downloads/som107ap_c_lab.pdf on March 24, 2022. 
31 CMS, MLN Fact Sheet: CLIA Program and Medicare Lab Services, December 2021.  Accessed at 
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNProducts/Downloads/CLIABrochure.pdf#:~:text=CLIA%20applies%20to%20all%20laboratories%20that%20examine%
20%E2%80%9Cmaterials,%2842%20Code%20of%20Federal%20Regulations%20%5BCFR%5D%20%C2%A7%20493.2%29 on 
March 22, 2022. 
32 CMS, Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency Updated as of 12/17/2020.  
Accessed at https://edit.cms.gov/files/document/frequently-asked-questions-faqs-clia-guidance-during-covid-19-emergency-
updated-12-17-2020.pdf on April 21, 2022. 
33 FDA, FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health 
emergencies, February 26, 2019.  Accessed at https://www.fda.gov/news-events/press-announcements/fda-cdc-and-cms-
launch-task-force-help-facilitate-rapid-availability-diagnostic-tests-during-public on March 22, 2022. 
34 Charter: Tri-Agency Task Force for Emergency Diagnostics.  Accessed at https://www.fda.gov/media/120328/download on 
April 21, 2022. 
35 FDA, FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health 
emergencies, February 26, 2019.  Accessed at https://www.fda.gov/news-events/press-announcements/fda-cdc-and-cms-
launch-task-force-help-facilitate-rapid-availability-diagnostic-tests-during-public on March 22, 2022. 
36 FDA, Information for Laboratories Implementing IVD Tests Under EUA, November 15, 2021.  Accessed at 
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/information-
laboratories-implementing-ivd-tests-under-eua?msclkid=fdb190afab7311ecb9885bf37f841ac5 on March 24, 2022. 
37 FDA Repeatedly Adapted Emergency Use Authorization Policies to Address the Need for COVID-19 Testing (OEI-01-20-00380). 
38 OIG, Improving Collaboration To Better Serve Our Nation.  Accessed at https://oig.hhs.gov/reports-and-publications/top-
challenges/2021/tmc6.asp) on June 22, 2022. 
Issue Brief: FDAs Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests 
OEI-01-20-00381  Endnotes | 13