March 29, 2020
Mr. Jeff Rose
Battelle Memorial Institute
505 King Ave.
Columbus, OH 43201
Dear Mr. Rose:
On March 28, 2020, based on your request, the U.S. Food and Drug Administration (FDA)
issued an Emergency Use Authorization (EUA) for the emergency use of the Battelle CCDS
Critical Care Decontamination System™ (hereafter “the Battelle Decontamination System”) at
the Battelle Memorial Institute, for use in decontaminating compatible N95 or N95-equivalent 1
respirators (“compatible N95 respirators”) 2 for reuse by healthcare personnel (HCP) 3 to prevent
exposure to pathogenic biological airborne particulates when there are insufficient supplies of
FFRs during the COVID-19 pandemic resulting from the Coronavirus Disease 2019 (COVID19) 4 pandemic.
On March 29, 2020, in response to your request to operate the Battelle Decontamination System
at multiple locations and additional information you provided, and having concluded that
revising the March 28, 2020 EUA is appropriate to protect the 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 March 29,
2020, letter in its entirety with the amendments 5 incorporated.

1

For purposes of this EUA, “N95-equivalent respirators” refers to respirators identified in Exhibit 1 of the EUA for
Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, available at
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization.
2
For purposes of this EUA, “compatible N95 respirators” means any N95 or N95-equivalent respirator that does not
contain cellulose-based materials. Respirators containing cellulose-based materials are incompatible with the
Battelle Decontamination System.
3
HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or
indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body
fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or
contaminated air. These HCP include, but are not limited to, emergency medical service personnel, nurses, nursing
assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students
and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient
care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical,
dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing,
and volunteer personnel.
4
On February 11, 2020, the virus tentatively named 2019-nCoV was formally designated as severe acute respiratory
syndrome coronavirus 2 (SARS-CoV-2). Also on February 11, 2020, the disease caused by SARS-CoV-2 was
formally designated as Coronavirus Disease 2019 (COVID-19). The new names are used throughout this document.
5
The amendments to the March 29, 2020 letter revise: (1) the scope of the EUA, authorizing use of the Battelle
Decontamination System operated by the Battelle Memorial Institute; and (2) the conditions of authorization for use
of the Battelle Decontamination System operated by the Battelle Memorial Institute.

 Page 2 – Mr. Jeff Rose, Battelle Memorial Institute
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic
Act (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. 6 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, including alternative products used as
medical devices, during the COVID-19 pandemic, subject to the terms of any authorization
issued under that section. 7
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 the Battelle Decontamination System, as
described in the Scope of Authorization (Section II) and pursuant to the Conditions of
Authorization (Section IV) of this letter.
I.

Criteria for Issuance of Authorization

I have concluded that the emergency use of the Battelle Decontamination System for
decontaminating compatible N95 respirators that are contaminated or potentially contaminated
with SARS-CoV-2 or other pathogenic microorganisms during the COVID-19 pandemic meets
the criteria for issuance of an authorization under Section 564(c) of the Act, because I have
concluded that:
1. SARS-CoV-2, the virus that causes COVID-19, can cause a serious or life-threatening disease
or condition, including severe respiratory illness, to humans infected by this virus;
2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that
the Battelle Decontamination System may be effective at preventing exposure to pathogenic
airborne particulates when there are insufficient supplies of FFRs during the COVID-19
pandemic by decontaminating, for a maximum of 20 decontamination cycles per respirator,
compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2
or other pathogenic microorganisms, and that the known and potential benefits of the Battelle
Decontamination System, when used to decontaminate compatible N95 respirators for reuse by
HCP to prevent exposure to pathogenic airborne particulates during FFR shortages during the
COVID-19 pandemic, outweigh the known and potential risks; and

6

U.S. Department of Health and Human Services, Determination of a Public Health Emergency and 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 7316 (February 4, 2020) (accessible at
https://www.fda.gov/media/135010/download).
7
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, March 24, 2020.

 Page 3 – Mr. Jeff Rose, Battelle Memorial Institute
3. There is no adequate, approved, and available alternative to the emergency use of the Battelle
Decontamination System for decontaminating compatible N95 respirators for reuse by HCP
during FFR shortages during the COVID-19 pandemic. 8,9
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 use of the Battelle Decontamination System operated by the Battelle Memorial
Institute, for use in decontaminating compatible N95 respirators that are contaminated or
potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, for a
maximum of 20 decontamination cycles per respirator, for reuse by HCP to prevent exposure to
pathogenic airborne particulates during the COVID-19 pandemic.
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 the authorized Battelle Decontamination System, when used
and labeled consistently with the Scope of Authorization of this letter (Section II), outweigh the
known and potential risks of such products.
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 the Battelle Decontamination
System may be effective at preventing HCP exposure to pathogenic airborne particulates during
FFR shortages during the COVID-19 pandemic by decontaminating compatible N95 respirators
that are contaminated or potentially contaminated with SARS-CoV-2 and other pathogenic
microorganisms, when used consistently 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 the Battelle
Decontamination System, when used to decontaminate compatible N95 respirators that are
contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic
microorganisms (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 Battelle Memorial Institute must provide the following information pertaining to the
emergency use of the authorized product before the decontamination process begins (i.e., before
a healthcare facility begins preparing and collecting compatible N95s for decontamination),
which are authorized to be made available to HCP and healthcare facilities:

8

No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
There are not sufficient quantities of FFRs to meet the needs of the U.S. healthcare system. These disposable N95
respirators are an integral part of routine patient care. Due to shortages of N95 respirators, HCP may need to treat
patients without personal protective equipment (PPE) or use a bandana or other less effective masks unless singleuse N95 respirators can be decontaminated for reuse. Providing a method for decontaminating compatible N95
respirators reduces stress on the supply chain and helps meet the needs of the healthcare system. Providing HCP
who are on the forefront of the COVID-19 response with FFRs is necessary in order to reduce the risk of illness in
HCP and increase their availability to provide care to affected patients or those suspected of having COVID-19.

9

 Page 4 – Mr. Jeff Rose, Battelle Memorial Institute
•
•
•

Instructions for Healthcare Personnel: Preparation of Compatible N95 Respirators for
Decontamination by the Battelle Memorial Institute Using the Battelle
Decontamination System (“Instructions for Healthcare Personnel”);
Instructions for Healthcare Facilities: Preparation and Collection of Compatible N95
Respirators for Decontamination by the Battelle Memorial Institute Using the Battelle
Decontamination System (“Instructions for Healthcare Facilities”); and
Labeling and instructions for use developed by Battelle Memorial Institute
(“Battelle”) that include the Fact Sheet, Instructions for Healthcare Personnel, and
Instructions for Healthcare Facilities set forth in this section (Section II).

In addition, compatible N95 respirators decontaminated by the authorized product must be
accompanied by the following labeling, developed by the Battelle Memorial Institute, upon
return to the healthcare facility:
•
Fact Sheet for Healthcare Personnel: Battelle Decontamination System for
Compatible N95 Respirators (“Fact Sheet”).
The Fact Sheet, Instructions for Healthcare Personnel, Instructions for Healthcare Facilities, and
Instructions for Use are referred to as “authorized labeling.”
The Battelle authorized labeling must be provided to HCP and healthcare facilities as directed in
Section II, and shall include the specified information as follows:
The Battelle Decontamination System is a self-contained decontamination device that
uses vapor phase hydrogen peroxide (VPHP) for decontamination of compatible N95
respirators that are contaminated or potentially contaminated with SARS-CoV-2. N95
respirators containing cellulose-based materials are not compatible with decontamination
by the Battelle Decontamination System.
Each decontamination cycle in the Battelle Decontamination System consists of injecting
VPHP into the decontamination chamber until achieving a saturated atmosphere indicated
by micro condensation; maintaining the VPHP exposure for a 150-minute dwell time; and
allowing the VPHP to off gas to a level of 1 ppm prior to post decontamination
processing. A minimum of five calibrated chemical indicators are dispersed throughout
the system to indicate a successful decontamination cycle. This decontamination system
enables the reuse of compatible N95 respirators that would otherwise be disposed of after
a single use. However, respirators that are visibly soiled must be discarded and not
reused or decontaminated.
Instructions for Healthcare Personnel are sent to all healthcare facilities requesting
decontamination of compatible N95 respirators and the facility should make these
instructions available to HCP to prepare their own individual, compatible N95 respirator
for decontamination. Using a permanent marker, the compatible N95 respirator is labeled
by the HCP (following the procedure established by the healthcare facility) with a unique
three-digit site code and a two-digit location identifier. The unique three-digit site code
corresponds to the return delivery address for each respirator following decontamination.

 Page 5 – Mr. Jeff Rose, Battelle Memorial Institute
Instructions for Healthcare Facilities are sent to all healthcare facilities requesting
decontamination of compatible N95 respirators. The facility should create a collection
station for compatible N95 respirators to be sent to Battelle for decontamination.
Collection stations should contain bags (“primary collection bag”) to collect compatible
N95 respirators prepared according to the Instructions for Healthcare Personnel. The
healthcare facility shall close the primary collection bag. The primary collection bag is
then placed into a secondary collection bag, and the facility will appropriately close and
decontaminate (using alcohol or other suitable decontaminant) the secondary collection
bag. The bags are then placed into rigid, closed boxes clearly labeled with biohazard
symbols, taped securely shut, and labeled outside with the three-digit site code and twodigit location identifier. According to the healthcare facility’s agreement with Battelle,
the facility should complete the chain of custody form provided by Battelle for each
shipment, and send to the designated Battelle location. Upon return of the
decontaminated compatible N95 respirators from Battelle to the healthcare facility, the
healthcare facility should review the provided chain of custody form indicating
successful decontamination, and inspect each compatible N95 respirator for visible
damage or soiling, as well as confirm the N95 respirator contains a numerical indicator of
the decontamination cycle. Any problems should be immediately reported to Battelle.
Battelle agrees to the following procedures pertaining to the authorized product:
Battelle shall enter into agreements with healthcare facilities requesting decontamination
of compatible N95 respirators, and provide such healthcare facilities with the authorized
labeling and chain of custody documentation for completion by the healthcare facility to
send to Battelle. Upon receipt of the compatible N95 respirators and chain of custody
documentation by Battelle, the box of compatible N95 respirators is barcoded and logged
into the Battelle Decontamination System tracking database and chain of custody. The
used compatible N95 respirator is loaded into the Battelle Decontamination System and
undergoes a decontamination cycle. Upon completion of each decontamination cycle,
each compatible N95 respirator is removed from the decontamination system. Each
compatible N95 respirator is labeled numerically (1, 2, 3, etc.) with a permanent marker
to indicate the number of decontamination cycles completed, up to a maximum of 20
cycles. After all decontaminated compatible N95 respirators are labeled, they are boxed
and returned to provider with a chain of custody form, which indicates successful
decontamination, and the Fact Sheet.
The emergency use of the Battelle Decontamination System 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)
described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1),
the authorized Battelle Decontamination System is authorized to be operated by Battelle
Memorial Institute for decontaminating compatible N95 respirators that are authorized to be used
by HCP in healthcare settings under the terms and conditions of this EUA. Changes to the
process, procedures, or labeling for the authorized product may require an EUA amendment

 Page 6 – Mr. Jeff Rose, Battelle Memorial Institute
subject to review and concurrence of the Division of Infection Control and Plastic and
Reconstructive Surgery Devices/OPEQ/CDRH and OCET/OCS/OC.
This EUA will cease to be effective when the HHS declaration that circumstances exist to justify
the EUA is terminated under Section 564(b)(2) of the Act or when the EUA is revoked under
Section 564(g) of the Act.
III. Waiver of Certain FDA Requirements
I am waiving the following requirements for the Battelle Decontamination System during the
duration of this EUA:
• applicable current good manufacturing practice requirements, including the quality
system requirements under 21 CFR Part 820 with respect to the authorized Battelle
Contamination System used in accordance with this EUA; and
• labeling requirements under the FD&C Act and FDA regulations, including unique
device identification requirements (see Subpart B of 21 CFR Part 801), except that the
Battelle Decontamination System must comply with the authorized labeling requirements
specified in this EUA (Section II).
IV. Conditions of Authorization
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
Battelle Memorial Institute
A) The Battelle Decontamination System shall only be operated by the Battelle Memorial
Institute (“Battelle”) and shall not be distributed to third parties.
B) Use of the Battelle Decontamination System on other types of personal protective equipment
is not authorized and would require a request for a separate EUA or marketing authorization
and data supporting such other use.
C) Battelle will make available to customers the authorized labeling for the Battelle
Decontamination System through posting on the Battelle website and will send the
appropriate authorized labeling to each healthcare facility when it returns each shipment of the
decontaminated respirators, consistent with Section II of this letter.
D) Battelle is authorized to decontaminate up to 10,000 compatible N95 respirators per chamber
load, consistent with the data provided to FDA. Battelle shall provide FDA weekly reports,
including data according to a testing plan (including data from chemical indicators and
biological indicators) for scale-up reviewed by FDA, regarding the decontamination of
compatible N95 respirators, including any reductions in decontamination ability. Battelle
shall provide FDA, in advance of establishing satellite facilities where Battelle will perform
decontamination using the Battelle Decontamination System, confirmation that all chambers,
critical parameters, logistics, processes, containment systems, and labeling are identical and in
place at all satellite facilities. After implementation, at the current and all satellite facilities, if
Battelle demonstrates any reduction in decontamination ability for a given site, Battelle shall
immediately notify FDA.

 Page 7 – Mr. Jeff Rose, Battelle Memorial Institute
E) All descriptive printed matter relating to the use of the Battelle Decontamination System shall
be consistent with the authorized labeling. No descriptive printed matter relating to the use of
the Battelle Decontamination System may represent or suggest that this product is safe or
effective for the prevention or treatment of COVID-19.
F) Battelle will have a process in place for reporting adverse events about the authorized product
and the decontaminated respirators of which they become aware and send such reports to
FDA, and will establish a process to collect information from healthcare facility customers
regarding degradation of decontaminated N95 respirators and reports of infection or potential
infection of users of the decontaminated N95 respirators and send such reports weekly to
FDA.
G) Battelle will 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.
H) Battelle will maintain records of the chain of custody of the N95 respirators sent to Battelle
for decontamination through use of a barcode system and tracking database.
I) Battelle will track the number of times a N95 respirator is decontaminated up to a maximum
of 20 decontamination cycles per N95 respirator. Battelle will maintain records of all
decontamination cycles.
J) Battelle is authorized to make available additional information relating to the emergency use
of the product that is consistent with, and does not exceed, the terms of this letter of
authorization.
K) Battelle will maintain records and provide reports to FDA of the routine monitoring and
testing of its personnel consistent with the monitoring and schedule set forth below:
• Battelle personnel are to be enrolled in the Battelle SARS-CoV-2 Fever Monitoring
Program.
• Battelle personnel will undergo routine testing for SARS-CoV-2 (subject to availability
of diagnostic tests).
• Battelle will keep records and provide weekly reports to FDA during the decontamination
system scale-up process (i.e., data on chemical indicators and biological indicators), and
weekly reports to FDA for a minimum of two weeks post-implementation of the full
scale-up of the decontamination process to monitor the safe use of the Battelle
Decontamination System by Battelle personnel.
• After the decontamination scale-up process is established and operational, Battelle will
provide bi-weekly reports and promptly notify FDA of adverse events relating to
infections and exposures of Battelle personnel to SARS-CoV-2.
Healthcare Facilities
L) Healthcare facilities using respirators that have undergone decontamination using the Battelle
Decontamination System (“the decontaminated respirators”) should make available to HCP
who are or may be using the decontaminated respirators the authorized Fact Sheet for
Healthcare Personnel that is required to be provided by Battelle.
M) Healthcare facilities using the decontaminated respirators should monitor HCP who use such
respirators for the signs and symptoms of potential infection with SARS-CoV-2 or other
respiratory infection and promptly report such information to Battelle, so that Battelle can
provide a weekly report to FDA consistent with Section IV.F of this EUA. Reports of adverse

 Page 8 – Mr. Jeff Rose, Battelle Memorial Institute
health indications should be reported up to and including 14 days after the last contact with
suspected SARS-CoV-2 virus.
N) Healthcare Facilities using the decontaminated respirators must inspect the decontaminated
respirators upon receipt from Battelle. Any discoloration or other signs of degradation with a
decontaminated respirator should promptly be reported to Battelle, and the healthcare facility
should dispose of such respirator.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of the Battelle Decontamination System during the COVID19 outbreak is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Section 564(g) of the Act.

Sincerely,
/S/
____________________________
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration

Enclosures