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EUA-Advanced-STERRAD-Letter

January 21, 2021
Ms. Laurie Cartwright Director, Worldwide Regulatory Affairs Advanced Sterilization Products, Inc. 33 Technology Irvine, California 92618
Dear Ms. Cartwright:
On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3(b)(1)(C)), the Secretary of the Department of Health and
D 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 Coronavirus Disease 2019 (COVID-19).1 Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of HHS then
E declared on March 24, 2020, that circumstances exist justifying the authorization of emergency
use of medical devices during the COVID-19 outbreak, subject to the terms of any authorization issued under that section.2
K On April 11, 2020, based on your3 request, the U.S. Food and Drug Administration (FDA) issued
an Emergency Use Authorization (EUA) for the emergency use of the Advanced Sterilization Products, Inc. (ASP) STERRAD 100S, NX, and 100NX Sterilization Systems4 (hereafter "ASP STERRAD Sterilization Systems") for use in decontaminating compatible N95 respirators5 for
O 1 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration V 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 7, 2020). 2 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, 85 FR 17335
E (March 27, 2020).
3 For ease of reference, this letter will use the term "you" and related terms to refer to Advanced Sterilization Products, Inc. (ASP). 4 This EUA, as originally issued on April 11, 2020 and as reissued on June 6, 2020 authorizes the emergency use of the ASP STERRAD 100S Sterilization System, the NX Sterilization System, and 100NX Sterilization System.
RWhen used to decontaminate compatible N95 respirators, the ASP STERRAD 100S Sterilization System must be
operated in the 100S cycle, the NX Sterilization System must be operated in the Standard cycle, and the 100NX Sterilization System must be operated in the Express cycle for decontamination of compatible N95 respirators. 5 In the June 6, 2020 letter, "compatible N95 respirators" were defined as any N95 or N95-equivalent respirators that do not contain cellulose-based materials or exhalation valves. The June 6, 2020 letter also defined "N95-equivalent respirators" as 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-legalregulatory-and-policy-framework/emergency-use-authorization.

Page 2 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
single-user6 reuse by healthcare personnel (HCP)7 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of filtering facepiece respirators resulting from the COVID-19 pandemic.8
On June 6, 2020, FDA reissued the April 11, 2020 letter in order to revise the compatible N95 respirators9 this decontamination system is authorized to decontaminate in order to address public health and safety concerns with certain respirators.
On January 21, 2021, in response to public health and safety concerns regarding the decontamination of certain respirators, FDA is reissuing the June 6, 2020 letter in order to revise the authorization the ASP STERRAD Sterilization Systems to include the following aspects:
1. Limitation of the respirator features that are considered to be compatible N95 respirators10 in which this decontamination system is authorized to decontaminate.
2. Incorporation of a post-authorization study to collect RWE to verify that compatible N95
D respirators are capable of adequate reuse after 2 decontamination cycles.11
The ASP STERRAD Sterilization Systems are no longer authorized to decontaminate compatible N95 respirators with antimicrobial agents or a duck-billed design. Additionally, a Condition of
E 6 Single-user reuse means that the same respirator is returned for reuse to the same healthcare personnel following
decontamination. FDA has revised this definition for clarity from the April 11, 2020 letter, in which this term was defined as "single-user reuse means that the same HCP should use the mask following decontamination." 7 HCP refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or
K 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
O 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). 8 The ASP STERRAD Sterilization Systems are FDA cleared for use in the sterilization of certain metal and nonmetal medical devices, which do not include N95 respirators (see K023290, K162007, and K160903 for the most
V recent clearances).
9 In the June 6, 2020, "compatible N95 respirators" were defined as non-cellulose containing respirators that do not have an exhalation valve that are either: (1) authorized in the NIOSH-Approved Air Purifying Respirators EUA; or (2) authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, which are available at https://www.fda.gov/emergency-preparedness-and-response/mcm-
E legal-regulatory-and-policy-framework/emergency-use-authorization. As described in the Scope of Authorization
(Section II), the ASP STERRAD Sterilization Systems was no longer authorized to decontaminate respirators that are authorized under the Non-NIOSH Approved Disposable Filtering Facepiece Respirators Manufactured in China EUA or authorized respirators that have exhalation valves.
R10 For purposes of this revised EUA, "compatible N95 respirators" are defined as any non-cellulose containing
respirators that do not have an exhalation valve, antimicrobial agents, or a duck-billed design, and that are either: (1) authorized in the NIOSH-Approved Air Purifying Respirators EUA; or (2) authorized and identified in Exhibit 1 of the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators, which are available at https://www.fda.gov/emergency-preparedness-and-response/mcmlegal-regulatory-and-policyframework/emergency-use-authorization. Please see FDA's website for further information on N95 respirators, available at https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respiratorsand-surgical-masks-face-masks. 11 Other minor corrections and clarifications have also been made during the review and edit process for reissuance of the January 21, 2021 letter.

Page 3 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
Authorization (Section IV.L) has been added in which you must conduct a post-authorization study to verify that compatible N95 respirators are adequate for reuse following 2 decontamination cycles. The maximum number of cycles can be increased following submission and review of RWE for greater than 2 decontamination cycles (see Section IV.M). These revisions are reflected in the Scope of Authorization (Section II), Conditions of Authorization (Section IV), and authorized labeling. Having concluded that revising the June 6, 2020 letter is appropriate to protect the public health or safety under Section 564(g)(2)(C) of the Act, FDA is reissuing the June 6, 2020 letter in its entirety with the revisions incorporated.
The ASP STERRAD Sterilization Systems were previously cleared by FDA as class II devices intended for use in the terminal sterilization of reusable medical devices in healthcare facilities. The ASP STERRAD Sterilization Systems are not cleared, approved, or subject to an approved investigational device exemption for use in decontaminating compatible N95 respirators, and therefore, require authorization for such use. Additionally, there are no FDA approved or cleared
D devices for decontaminating compatible N95 respirators, which are needed for use by HCP to
prevent exposure to pathogenic biological airborne particulates during the COVID-19 pandemic.
In evaluating this EUA, FDA reviewed the totality of scientific evidence available, which
E includes: demonstrated efficacy through extreme biological challenges of artificial soil and
resistant spores, without pre-sterilization cleaning, under simulated clinical misuse conditions, medical devices inoculated with artificial soil/spore suspension were tested, without precleaning, and demonstrated 6 log reduction in each ASP STERRAD Sterilization Systems
K decontamination cycle. Therefore, the effectiveness of decontaminating compatible N95
respirators in the ASP STERRAD Sterilization Systems decontamination cycles has been demonstrated through the previous simulated use testing.
Having concluded that the criteria for issuance of this authorization under Section 564(c) of the
O Act are met, I am authorizing the emergency use of the ASP STERRAD Sterilization Systems, as
described in the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section IV) of this letter.
V I. Criteria for Issuance of Authorization
I have concluded that the emergency use of the ASP STERRAD Sterilization Systems, as described in the Scope of Authorization (Section II of this letter), meets the criteria for issuance
E 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 Rvirus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the ASP STERRAD Sterilization Systems may be effective at decontaminating, for a maximum of 2 decontamination cycles per respirator, compatible N95 respirators for single-user reuse by HCP to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates, and that the known and potential benefits of the ASP

Page 4 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.

STERRAD Sterilization Systems, when used for such use, outweigh the known and potential risks of the use of such product; and

3. There is no adequate, approved, and available alternative to the emergency use of the ASP STERRAD Sterilization Systems for decontaminating compatible N95 respirators for single-user reuse by HCP to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates during FFR shortages during the COVID-19 pandemic12,13

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 ASP STERRAD Sterilization Systems, including the STERRAD 100S, STERRAD NX, and STERRAD 100NX Sterilization Systems as described below, for use in decontaminating compatible N95 respirators that are contaminated or potentially contaminated
D with SARS-CoV-2 or other pathogenic microorganisms, for no more than 2 decontamination
cycles per respirator, for single-user reuse by HCP to prevent exposure to pathogenic biological airborne particulates during the COVID-19 pandemic.
E The ASP STERRAD Sterilization Systems are not authorized for use in decontaminating
incompatible N95 respirators. N95 respirators containing cellulose-based materials, respirators that have exhalation valves, antimicrobial agents, and duck-billed design are not compatible with the STERRAD Sterilization Systems. The ASP STERRAD Sterilization Systems also are not
K authorized to decontaminate respirators authorized by the non-NIOSH-approved Disposable
Filtering Facepiece Respirators Manufactured in China EUA.
Authorized ASP STERRAD Sterilization Systems
O The ASP STERRAD Sterilization Systems must be operated using the STERRAD
decontamination cycles outlined in the following table:

V STERRAD Sterilization System
STERRAD 100S STERRAD NX STERRAD 100NX

STERRAD Decontamination Cycle 100S
Standard Express

RE 12 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.

13 There are not sufficient quantities of N95 respirators 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 single-use 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.

Page 5 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
The ASP STERRAD Sterilization Systems are intended for terminal sterilization of properly prepared (cleaned, rinsed, and dried) medical devices in healthcare facilities. For this emergency use, the STERRAD 100S Sterilization System must be operated in the 100S cycle, the STERRAD NX Sterilization System must be operated in the Standard cycle, and the STERRAD 100NX Sterilization System must be operated in the Express cycle to decontaminate compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms so that the respirators can be reused by HCP.
The ASP STERRAD Sterilization Systems are to be used with the cleared and commercially available STERRAD Cassettes, compatible sterilization pouches, such as Tyvek pouches with STERRAD Chemical Indicators, STERRAD Chemical Indicator Strips, SEALSURE Chemical Indicator Tape, and VELOCITY Biological Indicator/Process Challenge Devices. The ASP STERRAD Sterilization Systems are to be loaded with compatible N95 respirators that are individually pouched in Tyvek Pouches with STERRAD Chemical Indicator. The sterilizer may
D contain a capacity of ten pouches per sterilizer load. A Chemical Indicator or chemical indicator
tape identified for the ASP STERRAD Sterilization Systems must be placed in the chamber to verify sterilant exposure.
E The STERRAD decontamination cycles decontaminate utilizing hydrogen peroxide vapor.
Hydrogen peroxide vapor is generated by injecting aqueous hydrogen peroxide solution into the vaporizer subassembly where the solution is then concentrated and vaporized at relatively low temperatures through a process that utilizes a combination of heating and sub-ambient pressures
K created by an on-board vacuum pump. The vaporized hydrogen peroxide is then introduced into
the chamber under sub-ambient pressure to allow perfusion of the hydrogen peroxide throughout the chamber and, facilitating hydrogen peroxide contact with the surfaces to be sterilized. The vapor in the chamber is transformed into gas plasma using electrical energy. The chamber is then vented to allow the sterilization chamber to return to atmospheric pressure. This process is
O repeated an additional time to complete a full STERRAD decontamination cycle (i.e., the full
sterilization cycle is composed of two identical half-cycles). The ASP STERRAD Sterilization Systems use a disposable sterilant cassette that contains a 59% nominal hydrogen peroxide solution in a plastic cell pack and cassette shells.
V Validation and performance studies conducted by the firm indicate compatible N95 respirators
can be decontaminated through the STERRAD decontamination cycle of the ASP STERRAD Sterilization Systems a maximum of 2 times. The respirator reuse limit is based upon the
E filtration performance evaluation of the respirators that were decontaminated 2 times in the
above authorized STERRAD decontamination cycles of the ASP STERRAD Sterilization Systems.
RFollowing completion of the cycle, the chemical indicator's color is compared to the "PASS"
reference color. If the colors matched or the color present is lighter, the compatible N95 respirators have been exposed to the vaporized hydrogen peroxide. If the indicator does not match the "PASS" criteria, the compatible N95 respirators are not to be considered decontaminated and either re-run through the STERRAD decontamination cycle or discarded. Any visibly soiled (e.g., contaminated with mucous, blood, or other extraneous soil) or damaged

Page 6 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
respirators will not be decontaminated in the ASP STERRAD Sterilization Systems and will be immediately discarded.
The above described product is authorized to be accompanied with the following productspecific information (that will be made available at https://www.fda.gov/medicaldevices/emergency-situations-medical-devices/emergency-use-authorizations) pertaining to emergency use, and is required to be made available to healthcare personnel and healthcare facilities, respectively:
· Instructions for Healthcare Personnel: Preparation of Compatible N95 Respirators for Decontamination in ASP STERRAD Sterilization Systems; and
· Instructions for Healthcare Facilities: Decontamination of Compatible N95 Respirators in ASP STERRAD Sterilization Systems.
D In addition, following decontamination, compatible N95 respirators decontaminated by the ASP
STERRAD Sterilization Systems must be accompanied by the following labeling, developed by ASP, upon return of the respirators to the appropriate single-user HCP:
E · Fact Sheet for Healthcare Personnel: ASP STERRAD Sterilization Systems for Decontaminating Compatible N95 Respirators.
The Fact Sheet, Instructions for Healthcare Personnel, and Instructions for Healthcare Facilities
K are collectively referred to as "authorized labeling." The above described product, when
accompanied with the described labeling is authorized to be distributed to and administered under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.
O 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 ASP STERRAD Sterilization Systems, when used and labeled consistently with the Scope of Authorization of this letter (Section II), outweigh the known and potential risks of such products.
V 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 ASP STERRAD Sterilization Systems may be effective at decontaminating compatible N95 respirators for single-user reuse by
E HCP to prevent exposure to pathogenic biological airborne particulates during FFR shortages
during the COVID-19 pandemic, when used consistently with the Scope of Authorization (Section II) of this letter, pursuant to Section 564(c)(2)(A) of the Act.
RFDA has reviewed the scientific information available to FDA, including the information
supporting the conclusions described in Section I of this letter, and concludes that the ASP STERRAD Sterilization Systems (as described in the Scope of Authorization (Section II)), meet the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.
The emergency use of the ASP STERRAD Sterilization Systems must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the

Page 7 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
Conditions of Authorization (Section IV). Subject to the terms and conditions 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, the ASP STERRAD Sterilization Systems are authorized for emergency use, as described in the Scope of Authorization (Section II).
III. Waiver of Certain FDA Requirements
Pursuant to Section 564(e)(3) of the Act, with respect to the emergency use of a product for which an authorization under this section is issued, FDA may waive or limit, to the extent appropriate given the circumstances of the emergency, requirements regarding good manufacturing practices otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulations under this Act, including such requirements established under Section 520(f)(1) of the Act. FDA grants that waiver, including the quality system requirements
D under 21 CFR Part 820. IV. Conditions of Authorization
E Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
Advanced Sterilization Products, Inc. ("ASP")
K A. ASP must comply with the labeling requirements under 21 CFR 801 Subpart A (general labeling provisions), as well as those described in Section II of this letter, the Scope of Authorization.
O B. ASP must provide to all healthcare facility customers the authorized labeling before the decontamination process begins.
C. ASP must notify all healthcare facility customers about the conditions of this authorization
V applicable to healthcare facilities before the decontamination process begins.
D. ASP may request changes to this EUA for the ASP STERRAD Sterilization Systems14, including changes to the authorized labeling. Any request for changes to this EUA must be
E submitted to the Division of Infection Control and Plastic and Reconstructive Surgery/Office
of Product Evaluation and Quality (OPEQ)/Center for Devices and Radiological Health
R(CDRH). Such changes require appropriate authorization from FDA prior to implementation.
14 The following types of revisions may be authorized without reissuing this letter: (1) non-substantive editorial corrections to this letter; (2) new types of authorized labeling, including new fact sheets; (3) new carton/container labels; (4) changes to manufacturing processes, including tests or other authorized components of manufacturing; (5) new conditions of authorization to require data collection or study; (6) new instruments, associated software, components or materials in the authorized product or modifications in the way that the device is used. For changes of the type listed in (5) or (6), review and concurrence is required from the Office of Counterterrorism and Emerging Threats/Office of the Chief Scientist.

Page 8 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
E. ASP may request and be allowed to add compatible N95 respirator models under Condition D. To support such a request, STERIS must provide to FDA validation data to support new respirator models.
F. ASP may request and be allowed to increase the maximum capacity of compatible N95 respirators per decontamination cycle under Condition D. To support such a request, STERIS must provide FDA validation data to support the increased decontamination capacity.
G. Use of the ASP STERRAD Sterilization Systems 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.
H. ASP will have a process in place and adequate Medical Device Reporting procedures, in accordance with 21 CFR Part 803, to report to FDA adverse events of which ASP becomes
D aware related to the ASP STERRAD Sterilization Systems and compatible N95 respirators
that have undergone decontamination using the ASP STERRAD Sterilization Systems ("the decontaminated, compatible N95 respirators"). This includes, but is not limited to, reports from healthcare facilities concerning infection or potential infection of the healthcare facility
E personnel involved in the use of ASP STERRAD Sterilization Systems and users of the
decontaminated, compatible N95 respirators. Other examples of reportable events that may be relevant to the authorized product include, but are not limited to: allergic reactions or eye, mouth, or nose irritation, evidence that a decontaminated, compatible N95 respirator is unable
K to perform its essential function, events related to residuals or user contact with residuals (if
applicable), infection in decontaminated, compatible N95 respirator wearers, or concerns with the process control or malfunctions of the authorized product used to decontaminate the compatible N95 respirators.
O I. ASP will have a process in place to collect information on the performance of ASP STERRAD Sterilization Systems, including information regarding degradation of decontaminated, compatible N95 respirators, and evaluate this information to determine if adverse event reporting in accordance with 21 CFR Part 803 is warranted.
V J. ASP 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.
E K. ASP 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.
R L. ASP must collect and submit to FDA real-world use data for FDA review to confirm the continued fit and performance of compatible N95 respirators authorized under this EUA after undergoing two (2) cycles of decontamination. The authorized maximum number of two (2) decontamination cycles per compatible N95 respirator (Scope of Authorization (Section II)) will be maintained or revised based on the real-world use data.

Page 9 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
You must complete your study within 60 days of the date of this letter or before 1,500 compatible N95 respirators have been decontaminated using your system, whichever is later. You may seek an extension to complete your study where agreed upon by DHT4B/OHT4/OPEQ/CDRH. Your results must be submitted to DHT4B/OHT4/OPEQ/CDRH for review within 15 days of the study completion. Upon completion of FDA's review, you must publish the study results on your website.
At minimum, the study design must include the following testing with acceptance criteria and sampling:
1. Fit Testing (Required) a. Acceptance Criteria: 70% of the subjects pass b. Sampling: Minimum of 10 representative15 compatible N95 respirators (minimum of 5 male and 5 female subjects) following 2 decontamination cycles.
D c. Test Design: OSHA guidelines OSHA 1910.134 Appendix A Fit Testing Protocol16 2. Filtration Efficiency (Required) a. Acceptance Criteria: 95%
E b. Sampling: Minimum of 10 representative15 compatible N95 respirators following 2 decontamination cycles. c. Test Design: CDC guidelines Assessment of Filter Penetration Performance
and Fit for Decontaminated N95 Respirators, Section "Particulate Filter
K Efficiency Testing" on Page 5.17
3. Indelible Markings (Required) a. Acceptance Criteria: Markings must be clearly legible. b. Sampling: Minimum of 10 representative15 compatible N95 respirators from Fit Testing following 2 decontamination cycles.
O c. Test Design: Respirators should be visually inspected prior to Fit Testing. An agreement should be met between 2 people evaluating legibility with a form to complete with "yes" or "no" on legibility.
V M. Following completion of Condition L, ASP may request and be allowed to increase the maximum number of decontamination cycles per compatible N95 under Condition D. To support such a request, Technical Safety Services must provide to FDA information regarding filtration efficiency and respirator fit testing based on RWE, including, but not limited to, RE evidence collected in the study design and methods adopted in accordance with Condition L.
15 Samples must be collected for testing after the 2nd decontamination cycle (which is after the 3rd use, to confirm through real-world use data that respirators can withstand 2 cycles of decontamination and reuse). Test samples must include a representative variation of respirators that you are receiving for decontamination. Justification must be provided for the sample chosen, including materials, design characteristics, sizes, etc. Records regarding sample type, model, materials, number of decontamination cycles, etc., must be kept for each sample tested. 16 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134AppA 17 https://www.cdc.gov/niosh/npptl/respirators/testing/pdfs/NIOSHApproved_Decon_TestPlan10.pdf

Page 10 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.
Healthcare Facilities
N. Healthcare facilities shall notify ASP when they intend to use the ASP STERRAD Sterilization Systems for the emergency use, consistent with Section II of this letter.
O. Healthcare facilities shall make available to HCP who are or may be using the decontaminated, compatible N95 respirators the authorized Fact Sheet for Healthcare Personnel and Instructions for Healthcare Personnel that is required to be provided by ASP.
P. Healthcare facilities will have a process in place to report adverse events of which they become aware related to the ASP STERRAD Sterilization Systems and the decontaminated, compatible N95 respirators in accordance with 21 CFR Part 803. This includes, but is not limited to, monitoring personnel using the ASP STERRAD Sterilization Systems and HCP using the decontaminated, compatible N95 respirators for signs and symptoms of potential
D infection with SARS-CoV-2 or other respiratory infection and reporting such infections. Other
examples of reportable events that may be relevant to the authorized product include, but are not limited to: allergic reactions or eye, mouth, or nose irritation, evidence that a decontaminated, compatible N95 respirator is unable to perform its essential function, events
E related to residuals or user contact with residuals (if applicable), infection in decontaminated,
compatible N95 respirator wearers, or concerns with the process control or malfunctions of the authorized product used to decontaminate the compatible N95 respirators.
K Q. Healthcare facilities must inspect the decontaminated, compatible N95 respirators. Any discoloration or other signs of degradation with a decontaminated, compatible N95 respirator shall promptly be reported to ASP, and the healthcare facility must discard the respirator.
R. Healthcare facilities must track the number of times a compatible N95 respirator is
O decontaminated, up to a maximum of 2 decontamination cycles per compatible N95
respirator. Healthcare facilities must ensure that the decontaminated, compatible N95 respirator is returned to its previous user. Healthcare facilities shall maintain documentation for use of the ASP STERRAD Sterilization Systems consistent with current healthcare facility
V protocols.
Conditions Related to Advertising and Promotion
S. All descriptive printed matter, advertising, and promotional materials relating to the use of
E the ASP STERRAD Sterilization Systems 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)
Rand (q)(1) and (r) of the Act and FDA implementing regulations.
T. No descriptive printed matter, advertising, or promotional materials relating to the use of the ASP STERRAD Sterilization Systems may represent or suggest that such products are safe or effective for the decontamination of compatible N95 respirators for single-user reuse by HCP to prevent exposure to pathogenic biological airborne particulates.
U. All descriptive printed matter, advertising, and promotional materials relating to the use of the ASP STERRAD Sterilization Systems clearly and conspicuously shall state that:

Page 11 Ms. Laurie Cartwright, Advanced Sterilization Products, Inc.

· the ASP STERRAD Sterilization Systems have neither been cleared or approved by FDA, but has been authorized for emergency use by FDA under an EUA for the decontamination of compatible N95 respirators for single-user reuse by HCP to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates;

· the emergency use of the ASP STERRAD Sterilization Systems are authorized only for

the duration of the declaration that circumstances exist justifying the authorization of the

emergency use of medical devices during the COVID-19 outbreak, under Section

564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying this
D authorization is terminated under Section 564(b)(2) of the Act or the EUA is revoked under
Section 564(g) of the Act.

REVOKE Enclosures

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

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