Product Datasheet/Brochure
Table Of Contents
Page 6 – Sang Joon Han, Access Bio, Inc.
established performance characteristics of which you and authorized distributor(s)
become aware.
D. You and authorized distributor(s) must inform relevant public health authorities of this
EUA, including the terms and conditions herein, and any updates made to your product
and/or the authorized labeling.
E. Through a process of inventory control, you and authorized distributor(s) must maintain
records of the locations (e.g., pharmacies, doctor’s offices, etc.) to which your product is
distributed and the number of tests distributed to each location.
F. You and authorized distributor(s) must collect information on the performance of your
product and have a process in place to track adverse events, including any occurrence
of false positive or false negative results and significant deviations from the established
performance characteristics of the product of which you become aware and report any
such events to FDA in accordance with 21 CFR Part 803. Serious adverse events,
especially unexpected biosafety concerns, should immediately be reported to the
Division of Microbiology (DMD)/Office of Health Technology 7 (OHT7)-Office of In
Vitro Diagnostics and Radiological Health (OIR)/Office of Product Evaluation and
Quality (OPEQ)/Center for Devices and Radiological Health (CDRH) (via email:
CDRH-EUAReporting@fda.hhs.gov).
G. 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.
H. You and authorized distributor(s) 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.
Access Bio, Inc. (You)
I. You must notify FDA of any authorized distributor(s) of your product, including the
name, address, and phone number of any authorized distributor(s).
J. You must provide authorized distributor(s) with a copy of this EUA and communicate to
authorized distributor(s) any subsequent revisions that might be made to this EUA and its
authorized accompanying materials, including the authorized labeling.
K. You must make the authorized “CareStart COVID-19 Antigen Home Test Healthcare
Provider Instructions for Use” and the “Fact Sheet for Healthcare Professionals”
electronically available on your website. Additionally, you must provide the opportunity
to request a copy of the “CareStart COVID-19 Antigen Home Test Healthcare Provider
Instructions for Use” and “Fact Sheet for Healthcare Professionals” in paper form, and
after such request, promptly provide the requested labeling at no additional cost.