Product Datasheet/Brochure

Page 8 – Sang Joon Han, Access Bio, Inc.
S. You must evaluate the usability of the “CareStart COVID-19 Antigen Home Test User
Instructions” with individuals using only the paper instructions of your product in an
FDA agreed upon post authorization study within 2 months of the date of this letter
(unless otherwise agreed to with DMD/OHT7-OIR/OPEQ/CDRH). After submission to
and concurrence with the data by FDA, you must update the authorized labeling, as
applicable, to reflect the additional testing. Such labeling updates will be made in
consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
T. You must complete the agreed upon real-time stability study for your product and
notify DMD/OHT7-OIR/OPEQ/CDRH of the testing results as they become available
until completion of the study. After submission of the study data, and review and
concurrence with the data by FDA, you must update your product labeling accordingly.
Such labeling updates must be made in consultation with, and require concurrence of,
DMD/OHT7- OIR/OPEQ/CDRH.
U. You must evaluate the impact of SARS-CoV-2 viral mutations on your product’s
performance. Such evaluations must occur on an ongoing basis and must include any
additional data analysis that is requested by FDA in response to any performance
concerns you or FDA identify during routine evaluation. Additionally, if requested by
FDA, you must submit records of these evaluations for FDA review within 48 hours of
the request. If your evaluation identifies viral mutations that affect the stated expected
performance of your device, you must notify FDA immediately.
V. If requested by FDA, you must update your labeling within 7 calendar days to include
any additional labeling risk mitigations identified by FDA, such as those related to the
impact of viral mutations on test performance. Such updates will be made in
consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
Conditions Related to Printed Materials, Advertising and Promotion
W. 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.
X. No descriptive printed matter, advertising, or 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.
Y. 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 by
FDA under an EUA;