Product Datasheet/Brochure

Page 7 – Sang Joon Han, Access Bio, Inc.
L. 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, including requests to
make available additional authorized labeling specific to an authorized distributor. Such
additional labeling may use another name for the product but otherwise must be
consistent with the authorized labeling, and shall not exceed the terms of authorization of
this letter. Any request for changes to this EUA should be submitted to DMD/OHT7-
OIR/OPEQ/CDRH and require appropriate authorization from FDA prior to
implementation.
M. 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).
N. You must have lot release procedures and the lot release procedures, including the study
design and statistical power, must ensure that the product released for distribution meet
the clinical and analytical performance claimed in the authorized labeling.
O. If requested by FDA, you must submit your 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 them within 48 hours of the request.
P. You must evaluate the analytical limit of detection and assess traceability
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of your
product with any FDA-recommended reference material(s). After submission to and
concurrence with the data by FDA, you will update your labeling to reflect the
additional testing. Such labeling updates will be made in consultation with, and require
concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.
Q. You must further develop your mobile phone application or website to further facilitate
results reporting by the individual using your product, and submit to FDA such
application or website within 4 months of the date of this letter (unless otherwise agreed
to with DMD/OHT7-OIR/OPEQ/CDRH). After submission of the mobile phone
application or website to, and review of and concurrence with the developed mobile
phone application or website by FDA, you must update the authorized labeling. Such
labeling updates will be made in consultation with, and require concurrence of, FDA.
R. You must evaluate the clinical performance of your product to support the serial
screening claim in an FDA agreed upon post authorization clinical evaluation study
within 6 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 to reflect the additional testing. Such labeling
updates will be made in consultation with, and require concurrence of, DMD/OHT7-
OIR/OPEQ/CDRH.
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Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.