Product Datasheet/Brochure

Page 5 – Sang Joon Han, Access Bio, Inc.
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
(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:
Access Bio, Inc. (You) and Authorized Distributor(s)
7
A. Your product must comply with the following labeling requirements: the intended use
statement in 21 CFR 809.10(a)(2), (b)(2); adequate directions for use in 21 U.S.C. 352(f)
and 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 the “CareStart COVID-19
Antigen Home Test User Instructions” and the “Fact Sheet for Individuals” for your
product in the shipped kit using the “CareStart COVID-19 Antigen Home Test” box
labels and make these two documents electronically available on your website.
C. You and authorized distributor(s) must maintain records of customer complaint files and
report to FDA any significant complaints about usability or deviations from the
7
“Authorized Distributor(s)” are identified by you, Access Bio, Inc., in your EUA submission as an entity allowed
to distribute your product.