Everlywell COVID-19 Test Home Collection Kit DTC (Everlywell, Inc.) - Letter of Authorization
Summary
A Food and Drug Administration letter dated March 2, 2023 to Liz Kwo, MD, of Everlywell, Inc., reissuing the Emergency Use Authorization, EUA Number EUA203174, for the Everlywell COVID-19 Test Home Collection Kit DTC under Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §360bbb-3). After an amendment request received March 15, 2022, FDA reissues the July 1, 2021 letter with revisions that remove the under-18 population claim and Condition Q, modify labeling to mitigate the kit's high rejection rate and add new suppliers of saline tubes. The kit is authorized for self-collection of anterior nasal swab specimens at home by individuals 18 years or older, for testing at laboratories designated by Everlywell, Inc. It closes with the signature block of Jeffrey E. Shuren, Director, Center for Devices and Radiological Health.
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Full text
March 2, 2023
Liz Kwo, MD
Chief Medical Officer
Everlywell, Inc.
823 Congress Avenue
Austin, TX 78701
Device: Everlywell COVID-19 Test Home Collection Kit DTC
EUA Number: EUA203174
Company: Everlywell, Inc.
Indication: A direct to consumer product for collection of anterior nasal swab
specimens at home from individuals age 18 years or older (self-
collected), that are sent for testing with an in vitro diagnostic (IVD)
molecular test that is indicated for use with the Everlywell
COVID-19 Test Home Collection Kit DTC, and the IVD is
indicated for testing any individuals, including individuals without
symptoms or other reasons to suspect COVID-19.
Authorized Laboratories: Testing is limited to laboratories designated by Everlywell, Inc.
that are certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet the
requirements to perform high complexity tests.
Dear Dr. Kwo:
On February 13, 2021, based on your1 request, the Food and Drug Administration (FDA) issued
a letter authorizing the emergency use of the Everlywell COVID-19 Test Home Collection Kit
DTC, as a direct to consumer product for self-collecting anterior nasal swab (nasal) specimen at
home by any individual 18 years and older that are sent for testing with an in vitro diagnostic
(IVD) molecular test that is indicated for use with the Everlywell COVID-19 Test Home
Collection Kit DTC, and the IVD is indicated for testing any individuals, including individuals
without symptoms or other reasons to suspect COVID-19, pursuant to Section 564 of the
Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3). Testing was limited to
laboratories designated by Everlywell, Inc., that are certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263, and meet the requirements to
perform high-complexity tests. Based on your request, FDA reissued the letter on July 1, 2021.2
1
For ease of reference, this letter will use the term “you” and related terms to refer to Everlywell, Inc.
2
On July 1, 2021, the revisions to the February 13, 2021, letter and authorized labeling included: (1) updates to the
intended use to expand collection of anterior nasal (nasal) swab specimens at home to individuals age 18 years and
older (self-collected), 16 years and older (self-collected under adult supervision), or 2 years and older (collected
with adult assistance), (2) updates to the EUA Summary to include results of an updated sample stability and
Page 2 – Liz Kwo, MD, Everlywell, Inc.
On March 15, 2022, FDA received a request from you to amend your EUA. In response to this
request, and having concluded that revising the July 1, 2021, EUA is appropriate to protect
public health or safety under section 564(g)(2)(C) of the Act (21 U.S.C. § 360bbb-3(g)(2)(C)),
FDA is reissuing the July 1, 2021, letter in its entirety with the revisions incorporated.3 Pursuant
to section 564 of the Act, Scope of Authorization (Section II) and Conditions of Authorization
(Section IV) of this reissued letter, your product4 is now intended for the indication described
above.
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the
Department of Health and Human Services (HHS) determined that there is a public health
emergency that has a significant potential to affect national security or the health and security of
United States citizens living abroad, and that involves the virus that causes COVID-19.
Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of
HHS then declared on March 24, 2020, that circumstances exist justifying the authorization of
emergency use of medical devices during the COVID-19 outbreak, subject to the terms of any
authorization issued under that section.5
FDA considered the totality of scientific information available in authorizing the emergency use
of your product for the indication above. A summary of the performance information FDA
relied upon is contained in the EUA Summary (identified below).
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
Act are met, I am authorizing the emergency use of your product, described in the Scope of
Authorization of this letter (Section II), subject to the terms of this authorization.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of your product meets the criteria for issuance of an
authorization under Section 564(c) of the Act, because I have concluded that:
1. The SARS-CoV-2 can cause a serious or life-threatening disease or condition,
including severe respiratory illness, to humans infected by this virus;
updated human usability studies including a study in minors, (3) updates to the Fact Sheet for Individuals and the
instructions for anterior nasal swab collection to reflect the revised intended use and/or language used in more recent
letters of authorization, and (4) update Condition Q below as a result of the new intended use.
3
The revisions to the July 1, 2021, letter and authorized labeling include: (1) removal of the “under 18” population
claim from the intended use, (2) removal of Condition of Authorization Q (from the July 1, 2021, letter) which was
both fulfilled and is no longer applicable with the removal of the “under 18” intended use population, (3) labeling
modifications to mitigate the high rejection rate observed for the kit, and (4) add new suppliers of saline tubes used
with the kit.
4
For ease of reference, this letter will use the term “your product” to refer to the Everlywell COVID-19 Test Home
Collection Kit DTC used for the indication identified above.
5
U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations
Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 17335
(March 27, 2020)
Page 3 – Liz Kwo, MD, Everlywell, Inc.
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe
that your product may be effective in diagnosing COVID-19, by serving as an appropriate
means to collect and transport human specimens so that an authorized laboratory can
detect SARS-CoV-2 RNA from the home-collected human specimen, and that the known
and potential benefits of your product when used for diagnosing COVID-19, outweigh the
known and potential risks of your product; and
3. There is no adequate, approved, and available alternative to the emergency use of
your product. 6
II. Scope of Authorization
I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is
limited to the indication above.
Authorized Product Details
Your product is a direct to consumer product for collection of anterior nasal swab specimens at
home from individuals age 18 years or older (self-collected), that are sent for testing with an in
vitro diagnostic (IVD) molecular test that is indicated for use with your product, and the IVD is
indicated for testing any individuals, including individuals without symptoms or other reasons to
suspect COVID-19. Testing is limited to laboratories designated by Everlywell, Inc. that are
certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
§263a,and meet the requirements to perform high complexity tests.
When using your product, individuals must follow all specimen collection and mailing
instructions provided with the kit. The Everlywell COVID-19 Test Home Collection Kit DTC
includes the following materials or other authorized materials: poly mailer, 2D barcode label,
anterior nasal swab, transport medium kit, kit ID stickers, return box, UN3373 label, medium
alcohol prep pad, absorbent sheet, small biohazard bag, inner box tray, help and contact number
insert, shipping and preparation instructions, collection instructions, Fact Sheet for Individuals,
welcome panel with kit ID, white tray, and return shipping label.
All test results are delivered to the user via Everlywell’s online portal. Individuals with positive
or invalid/indeterminate results will be contacted by a healthcare provider. 7 The direct to
consumer home collection system is intended to enable users to access information about their
COVID-19 infection status that could aid with determining if isolation or quarantine is
appropriate and to assist with healthcare decisions after discussion with a healthcare provider.
The Everlywell COVID-19 Test Home Collection Kit DTC is not a substitute for visits to a
healthcare provider. The information provided by this kit when combined with an authorized test
should not be used to start, stop, or change any course of treatment unless advised by your
healthcare provider.
6
No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
7
For this EUA, a healthcare provider includes any health professional with prescribing abilities, including, but is not
limited to, physicians, nurses, pharmacists, technologists, laboratory directors, and epidemiologists.
Page 4 – Liz Kwo, MD, Everlywell, Inc.
The labeling entitled “COVID-19 Test Home Collection Kit DTC Instructions,” “Everlywell
COVID-19 Test Home Collection Kit DTC” box label, the EUA Summary (available at
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-
authorizations-medical-devices/in-vitro-diagnostics-euas), the following standard operating
procedures (SOPs): “Receiving and Processing Everlywell Samples,” and the following fact
sheet pertaining to the emergency use, is required to be made available as set forth in the
Conditions of Authorization (Section IV), and are collectively referred to as “authorized
labeling”:
· Fact Sheet for Individuals: Everlywell, Inc. - Everlywell COVID-19 Test Home
Collection Kit DTC
The above described product, when accompanied by the authorized labeling provided as set forth
in the Conditions of Authorization (Section IV), is authorized to be distributed and used under
this EUA, despite the fact that it does not meet certain requirements otherwise required by
applicable federal law.
I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that
the known and potential benefits of your product, when used consistent with the Scope of
Authorization of this letter (Section II), outweigh the known and potential risks of your product.
I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific
evidence available to FDA, that it is reasonable to believe that your product may be effective in
diagnosing COVID-19, when used consistent with the Scope of Authorization of this letter
(Section II), pursuant to Section 564(c)(2)(A) of the Act.
FDA has reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I above, and concludes that your product (as
described in the Scope of Authorization of this letter (Section II)) meets the criteria set forth in
Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of your product under this EUA must be consistent with, and may not
exceed, the terms of this letter, including the Scope of Authorization (Section II) and the
Conditions of Authorization (Section IV). Subject to the terms of this EUA and under the
circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) of
the Act described above and the Secretary of HHS’s corresponding declaration under Section
564(b)(1) of the Act, your product is authorized for the indication above.
III. Waiver of Certain Requirements
I am waiving the following requirements for your product during the duration of this EUA:
· Current good manufacturing practice requirements, including the quality system
requirements under 21 CFR Part 820 with respect to the design, manufacture,
packaging, labeling, storage, and distribution of your product, but excluding Subpart
H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I
Page 5 – Liz Kwo, MD, Everlywell, Inc.
(Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21
CFR 820.250).
IV. Conditions of Authorization
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
Everlywell, Inc. (You) and Authorized Distributor(s) 8
A. Your product must comply with the following labeling requirements pursuant to FDA
regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate
directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); appropriate
limitations on the use of the device including information required under 21 CFR
809.10(a)(4); and any available information regarding performance of the device,
including requirements under 21 CFR 809.10(b)(12).
B. You and authorized distributor(s) must make available all instructions related to the self-
collection of anterior nasal swab specimens using the Everlywell COVID-19 Test Home
Collection Kit DTC and the Fact Sheet for Individuals both in the shipped kit and on your
website(s).
C. You and authorized distributor(s) must inform authorized laboratories and relevant public
health authorities of this EUA, including the terms and conditions herein, and any
updates made to your product, or the authorized labeling.
D. Through a process of inventory control, you and authorized distributor(s) must maintain
records of the numbers and locations to which your product is distributed.
E. You and authorized distributor(s) must maintain customer complaint files on record. You
will report to FDA any significant complaints about usability or deviations from the
established performance characteristics of the product of which you become aware.
F. You and authorized distributor(s) are authorized to make available additional information
relating to the emergency use of your product that is consistent with, and does not exceed,
the terms of this letter of authorization.
Everlywell, Inc. (You)
G. You must notify FDA of any authorized distributor(s) of your product, including the
name, address, and phone number of any authorized distributor(s).
8
“Authorized Distributor(s)” are identified by you, Everlywell, Inc., in your EUA submission as an entity allowed to
distribute the Everlywell COVID-19 Test Home Collection Kit DTC.
Page 6 – Liz Kwo, MD, Everlywell, Inc.
H. You must notify FDA of any authorized laboratories designated by Everlywell, Inc. to
use your product, including the name, address, and phone number of any authorized
laboratories.
I. You must provide authorized distributor(s) and authorized laboratories with a copy of this
EUA and communicate any subsequent amendments that might be made to this EUA and
its authorized labeling.
J. You must ensure that the authorized laboratories using your product have a process in
place for reporting test results to you, individuals, healthcare providers and relevant
public health authorities, as appropriate.
K. You must maintain records of the authorized laboratories and test usage.
L. You must collect information on the performance of your product. You must report to
FDA any suspected occurrence of false positive and false negative results and significant
deviations from the established performance characteristics of your product of which you
become aware.
M. You may request changes to this EUA for your product, including to the Scope of
Authorization (Section II in this letter) or to the authorized labeling. Any request for
changes to this EUA should be submitted to the Division of Microbiology (DMD)/Office
of Health Technology 7 (OHT7)/Office of Product Evaluation and Quality
(OPEQ)/Center for Devices and Radiological Health (CDRH) and require appropriate
authorization from FDA prior to implementation.
N. You must comply with the following requirements pursuant to FDA regulations: 21 CFR
820 Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I
(Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21
CFR 820.250).
O. You must have lot release procedures and the lot release procedures, including the study
design and statistical power, must ensure that your product released for distribution has
the clinical and analytical performance claimed in the authorized labeling.
P. If requested by FDA, you must submit lot release procedures to FDA, including sampling
protocols, testing protocols, and acceptance criteria, that you use to release lots of your
product for distribution in the U.S. If such lot release procedures are requested by FDA,
you must provide it within 48 hours of the request.
Q. You must have a process in place to track adverse events associated with the Everlywell
COVID-19 Test Home Collection Kit DTC, including any occurrence of false results and
report to FDA pursuant to 21 CFR Part 803. Serious adverse events, especially
unexpected biosafety concerns, must immediately be reported to
DMD/OHT7/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov).
Page 7 – Liz Kwo, MD, Everlywell, Inc.
R. You must have a process in place for reporting all test results to individuals who use the
Everlywell COVID-19 Test Home Collection Kit DTC. This process must include a
requirement that all positive and invalid/indeterminate results must be reported to
individuals who self-collected specimens using the Everlywell COVID-19 Test Home
Collection Kit DTC by a HCP, defined in footnote 6. This process must ensure the Fact
Sheet for Individuals for the authorized IVD molecular test used on the specimen is made
available to individuals with the test result, for example via weblink.
S. You must have a healthcare provider available to provide information and counseling to
individuals use the Everlywell COVID-19 Test Home Collection Kit DTC. You will
ensure these healthcare providers have the Fact Sheet for Healthcare Providers that is
relevant to the authorized IVD molecular test used on the specimen, for reference.
Authorized Laboratories
T. Authorized laboratories using your product will use it only in conjunction with COVID-
19 IVD molecular tests that are indicated for use with the Everlywell COVID-19 Test
Home Collection Kit DTC.
U. Authorized laboratories testing specimens self-collected using your product must follow
the “Receiving and Processing Everlywell Samples” specimen accessioning protocol
provided with your product when accepting specimens for testing.
V. Authorized laboratories using your product must have a process in place for reporting test
results to relevant public health authorities, as appropriate. Authorized laboratories using
your product must also have a process in place for reporting test results to you via the
agreed upon process, as described in the EUA Summary, for your product.
W. Authorized laboratories must collect information on the performance of your product and
report to DMD/OHT7/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov)
and you (via email: covidsupport@everlywell.com or 512-309-5588) any suspected
occurrence of false positive or false negative results and significant deviations from the
established performance characteristics of the test of which they become aware.
Everlywell, Inc. (You), Authorized Distributor(s) and Authorized Laboratories
X. You, authorized distributor(s) and authorized laboratories using your product must ensure
that any records associated with this EUA are maintained until otherwise notified by
FDA. Such records will be made available to FDA for inspection upon request.
Conditions Related to Printed Materials, Advertising and Promotion
Y. All descriptive printed matter, advertising, and promotional materials relating to the use
of your product shall be consistent with the authorized labeling, as well as the terms set
forth in this EUA and meet the requirements set forth in section 502(a), (q)(1), and (r) of
the Act, as applicable, and FDA implementing regulations.
Page 8 – Liz Kwo, MD, Everlywell, Inc.
Z. No descriptive printed matter, advertising, and promotional materials relating to the use
of your product may represent or suggest that this test is safe or effective for the detection
of SARS-CoV-2.
AA. All descriptive printed matter, advertising, and promotional materials relating to the use
of your product shall clearly and conspicuously state that:
· This product has not been FDA cleared or approved, but has been authorized for
emergency use by FDA under an EUA;
· This product has been authorized only for the home collection and maintenance of
anterior nasal swab specimens as an aid in detection of nucleic acid from SARS-CoV-
2, not for any other viruses or pathogens; and,
· The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency use of
medical devices under Section 564(b)(1) of the Federal Food, Drug and Cosmetic
Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization
is revoked sooner.
The emergency use of your product as described in this letter of authorization must comply with
the conditions and all other terms of this authorization.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of medical devices during the COVID-19 outbreak is
terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the
Act.
Sincerely,
____________________________
Jeffrey E. Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
Food and Drug Administration
Enclosure
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