FDA  -  Respirators  (FaceMask) Filtering Facepiece  Respirators >> FFR.     http://mask.bz/fda     compiled by: vic 15902157790   4-1-2020
                    (for inter-office study use only.)      https://www.fda.gov/     https://www.fda.gov/medical-devices   toll-free 24 hr./day: 1-888-INFO-FDA   (1-888-463-6332)

**Conclusion: As of 3-28-2020, called "KN95 FFR Mask" can not Export  to USA as "N95 grade Mask".
                        Although, N95 is not a Trade-Mark, but is a special medical use Product Name.
                        It represent  that Mask is approved by FDA-NIOSH.  

                        In USA Hosipital is requested by FDA must be use N95 grade  Masks. vic 4-1-2020(see details below.)
 

or FDA with NIOSH-Approved Mask OK.

**Study Subject: How "Mask.bz" to assist a good CN Mask mfr (which they don't have FDA cert current.)   export to USA w/o get Trouble.
*Suggest:  1. Importers verify (prior) with local USA Customs Office for each shipment.  Entrance Paper work, Procudure, Restriction....
                2. Suggest use Blank Carton, Simple printed Box (only printing.... Goods: "Home/Garden use Dust prevention mask",
                       with QR code, Expire date. Material content...    Application: good for in House/Garden use, QR code link/shown Mask design, mfr process, 
                       cleaness, plant size.., made in China.. & Liability waiver statement...)    
                3. Target  price $0.25 as brand promotion item...or $0.50 Vending machine sales item...  each mask has special ID/Logo for this human protection Act..                                         


*FDA's approved/registered mfr FEI number Search....


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 3-28-2020   FDA Letter   Re. Approved Importing Masks Quality  Original Letter (PFD) click here..

 March 28, 2020
To: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece  Respirators (FFR);
Health Care Personnel;
Hospital Purchasing Departments and Distributors;
Importers and Commercial Wholesalers; and
Any Other Applicable Stakeholders.
Dear Stakeholder:
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 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. Pursuant to Section
564 of the Act, and on the basis of such determination, the Secretary of HHS then declared on
March 2, 2020, that circumstances exist justifying the authorization of emergency use of
personal respiratory protective devices during the Coronavirus Disease 2019 (COVID-19)
outbreak, subject to the terms of any authorization issued under that Section.1
On March 24, 2020, in response to this evolving public health emergency and continued
filtering facepiece respirator (FFR or respirator) shortages, FDA concluded based on the totality
of scientific evidence available that certain imported disposable FFRs that are not NIOSH￾
   approved are appropriate to protect the public health or safety (as described under section II
Scope of Authorization) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act)
(21 U.S.C. § 360bbb-3).
On March 28, 2020, to further address the shortage of disposable FFRs, FDA determined it was
necessary to reissue the March 24, 2020 letter in order to amend the Scope of Authorization
(Section II) to additionally authorize the use of authorized respirators that have been
decontaminated pursuant to the terms and conditions of an authorized decontamination system.2
 
1 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). U.S. Department of Health and Human
Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the Federal,
Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. March 2, 2020.

2 For purposes of this EUA, an “authorized decontamination system” means any decontamination system that has
been issued an EUA. Authorized decontamination systems can be found on FDA’s Emergency Use Authorization
webpage, available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and￾policy-framework/emergency-use-authorization.

Page 2 – Stakeholders for Non-NIOSH-Approved Imported FFRs
Having concluded that revising the 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 24, 2020 letter in its entirety with the amendment3 incorporated to authorize the emergency use of:

1) Authorized respirators listed in Exhibit 1 for use in healthcare settings by
healthcare personnel (HCP)4 when used in accordance with CDC
recommendations to prevent wearer exposure to pathogenic biological airborne
particulates during FFR shortages resulting from the COVID-19 outbreak; and,

2) Authorized respirators listed in Exhibit 1 that have been decontaminated
pursuant to the terms and conditions of an authorized decontamination system
for use in healthcare settings by HCP when used in accordance with CDC
recommendations to prevent wearer exposure to pathogenic biological airborne
particulates during FFR shortages resulting from the COVID-19 outbreak.
This EUA does not affect the previous March 2, 2020, EUA (reissued on March 27, 2020, and
again on March 28, 2020), which authorizes, in part, the emergency use of certain respirators
approved by NIOSH, in accordance with 42 CFR Part 84, as non-powered air-purifying
particulate FFRs for use in healthcare settings by HCP to prevent wearer exposure to pathogenic
biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak,
pursuant to Section 564 of the Act.
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 authorized respirators, as described in
the Scope of Authorization (Section II) and pursuant to the Conditions of Authorization (Section
IV) of this letter for use in healthcare settings by HCP when used in accordance with CDC
recommendations to prevent wearer exposure to pathogenic biological airborne particulates
during FFR shortages resulting from the COVID-19 outbreak. For the most current CDC recommendations on optimizing respirator use, please visit CDC’s
webpage: Strategies for Optimizing the Supply of N95 Respirators. This EUA does not permit
use of authorized respirators by the general public.
I. Criteria for Issuance of Authorization
I have concluded that the emergency use of authorized respirators as described in the Scope of
Authorization (Section II) of this letter for use in healthcare settings by HCP to prevent wearer
 
3 The March 28, 2020 amendment to the March 24, 2020 letter revises the scope of authorized respirators to include
authorized respirators listed in Exhibit 1 that are decontaminated using an authorized decontamination system.
4 Healthcare personnel 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 healthcare personnel 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.

Page 3 – Stakeholders for Non-NIOSH-Approved Imported FFRs
exposure to pathogenic biological airborne particulates during FFR shortages resulting from the
COVID-19 outbreak 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 authorized respirators may be effective in preventing HCP exposure to pathogenic
biological airborne particulates during FFR shortages, and that the known and potential
benefits of the authorized respirators, when used to prevent HCP exposure to such
particulates during FFR shortages during COVID-19, outweigh the known and potential
risks of such products; and
3. There is no adequate, approved, and available alternative to the emergency use of the
certain respirators for preventing HCP exposure to such particulates during FFR
shortages to prevent disease spread.5,6
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 authorized respirators listed in Exhibit 1, and to authorized respirators
listed in Exhibit 1 that have been decontaminated pursuant to the terms and conditions of an
authorized decontamination system, for use in healthcare settings by HCP as recommended by
CDC to prevent wearer exposure to pathogenic biological airborne particulates during FFR
shortages resulting from the COVID-19 outbreak.
Respirators Eligible for Authorization under this EUA
Respirators meeting the criteria in the following two categories are eligible for authorization
under this EUA as described in this section (Scope of Authorization (Section II)). Respirators
that satisfy the eligibility criteria in numerals 1 and/or 2, and that meet the terms and conditions
(Conditions of Authorization (Section IV)) of this EUA will be listed in Exhibit 1 pursuant to the
procedure outlined below. The categories of eligibility are as follows:
1. Disposable FFRs that have been designed, evaluated, and validated to meet a given
performance standard and have corresponding acceptable product classifications,
as follows:
 
5 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
6 There are not sufficient quantities of FFRs that are both NIOSH-approved and meet FDA regulatory requirements
to meet the needs of the U.S. healthcare system. These disposable respirators are an integral part of routine patient
care. Providing HCP who are on the forefront of the COVID-19 response with FFRs consistent with the CDC’s
guidance and recommendations is necessary in order to reduce the risk of illness in HCPs and increase their
willingness to provide care to affected patients or those suspected of having COVID-19.
Page 4 – Stakeholders for Non-NIOSH-Approved Imported FFRs
Table 1:

2. Disposable FFRs which have a marketing authorization in one of the following
regulatory jurisdictions:
• European CE Mark
• Australian Register of Therapeutic Goods (ARTG) Certificate of Inclusion
• Health Canada Licence
• Japan Pharmaceuticals and Medical Device (PMDA)/Ministry of Health
Labour and Welfare (MHLW)
In order to be added to Exhibit 1 as an authorized respirator under this EUA, manufacturers
and/or importers must send a request to FDA by email of their intent to import non-NIOSH
approved disposable respirators that are eligible for authorization under 1 and/or 2 above. The
manufacturer or importer should send a request to be authorized under this EUA by email to
FDA at CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the following information,
which will allow FDA to determine whether the disposable respirator meets the criteria to be
added to Exhibit 1 as an authorized respirator under this EUA:
• Specify the manufacturer, model number(s), marketing authorization/certificate from
another regulatory authority or conformity assessment body acting on their behalf
(including the authorization number (if any)), certificate of conformity (if available),
 
7 Canada is not listed because it allows self-declaration to NIOSH or equivalent standards.

Page 5 – Stakeholders for Non-NIOSH-Approved Imported FFRs
applicable performance standards that their product meets, and any applicable
guidance documents. • An estimate of the number of respirators you are planning to import during the public
health emergency, • A copy of the product labeling. Respirators must comply, at a minimum, with the
labeling requirements in conditions A and B under the Conditions of Authorization
(Section IV) of this letter.
Once FDA receives the above information, and any additional information it needs to confirm
applicability of the imported disposable respiratory with eligibility under the categories outlined
above, FDA will notify the manufacturer of the inclusion of their authorized respirator(s) in
Exhibit 1 under this EUA by replying to the manufacturer’s or importer’s email.
Authorized Respirators
The above described authorized respirators listed in Exhibit 1, when labeled as described in this
letter, are authorized to be distributed to and used in healthcare settings by HCPs when used in
accordance with CDC’s recommendations under this EUA, despite the fact that they do not meet
certain requirements otherwise required by applicable federal law.
Additionally, authorized respirators listed in Exhibit 1 that have been decontaminated using an
authorized decontamination system remain authorized under this EUA to be used in healthcare
settings by HCP when used in accordance with the terms and conditions of the authorized
decontamination system without the need for any action by the respirators’ manufacturer, despite
the fact that they do not meet certain requirements otherwise required by applicable federal law.
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 respirators when used 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 authorized respirators may be
effective at preventing HCP exposure to certain particulates to prevent disease spread, 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 conclude that the authorized
respirators, when used in healthcare settings to prevent HCP exposure to certain particulates to
prevent disease spread (as described in the Scope of Authorization of this letter (Section II)),
meet the criteria set forth in Section 564(c) of the Act concerning safety and potential
effectiveness.
The emergency use of the authorized respirators under this EUA must be consistent with, and
may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the

Page 6 – Stakeholders for Non-NIOSH-Approved Imported FFRs
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 respirators are authorized to be used in healthcare settings by HCP under the
terms and conditions of this EUA. EUA amendments may be undertaken as needed with
concurrence of, OST/CDRH, Division of Infection Control and Plastic and Reconstructive
Surgery/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 applicable current good manufacturing practice requirements, including the quality system requirements
under 21 CFR Part 820 with respect to the design, manufacture, packaging,
labeling, storage, and distribution of the authorized respirators that are used in accordance with
this EUA.
IV. Conditions of Authorization
Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this
authorization:
Manufacturers of Authorized Respirators
A. Manufacturers of authorized respirators are required to publish the intended use and other
instructions (such as fit testing, etc.) about all authorized models that are imported and
authorized under this EUA on their website in English. Additionally, manufacturers must
notify FDA by emailing FDA at CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov of
the website address (URL) that meets this condition. FDA will make this information
available to the public on its EUA website at
    https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe 
Manufacturers must notify FDA of any changes to this page.
B. In addition to the above electronic labeling condition, manufacturers of authorized
respirators are additionally required to include a letter, in English, that can be distributed
to each end user facility (e.g., each hospital, etc.) that receives the authorized respirator
model. This letter must include the authorized respirator’s manufacturer, model, intended
use, manufacturer’s webpage (if applicable), etc.
C. Manufacturers of authorized respirators will notify the importer (if applicable) of the
terms and conditions of this EUA and ensure that the end user facility (e.g., each hospital,
etc.) that receives the authorized respirators also receives the information required under
Condition B.

Page 7 – Stakeholders for Non-NIOSH-Approved Imported FFRs
D. Manufacturers of authorized respirators will have a process in place for reporting adverse
events of which they become aware and send such reports to FDA.
E. All descriptive printed material relating to the use of the authorized respirators in the
United States shall be consistent with applicable CDC recommendations for use during
the COVID-19 outbreak, as well as the terms set forth in this EUA.
F. No descriptive printed matter relating to the use of the authorized respirators in the
United States may represent or suggest that the product is safe or effective for the
prevention of COVID-19.
G. Manufacturers of authorized respirators 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. Manufacturers of authorized respirators that are decontaminated by an authorized
decontamination system are not responsible for any additional conditions that may apply
to the manufacturer and/or operator of the decontamination system, unless they are the
same manufacturer.
Importers
I. All descriptive printed material relating to the use of the authorized respirators shall be
consistent with applicable CDC recommendations for use during the COVID-19
outbreak, as well as the terms set forth in this EUA.
J. No descriptive printed material relating to the use of the authorized respirators may
represent or suggest that the product is safe or effective for the prevention of COVID-19.
K. Importers of authorized respirators will notify manufacturers of the terms and conditions
of this EUA and ensure that the end user facility (e.g., each hospital, etc.) that receives
the authorized respirators also receives the information required under Condition B.
L. Importers of authorized respirators will ensure that any records associated with this EUA
are maintained until the end of this public health emergency.
Manufacturers and/or Operators of Authorized Decontamination Systems
M. Each manufacturer and/or operator of an authorized decontamination system for
decontamination of authorized respirators must comply with the Conditions of
Authorization and authorized labeling as set forth in the Letter of Authorization for the
authorized decontamination system.
The emergency use of the authorized respirators as described in this letter of authorization must
comply with the conditions and all other terms of this authorization.
Page 8 – Stakeholders for Non-NIOSH-Approved Imported FFRs
V. Duration of Authorization
This EUA will be effective until the declaration that circumstances exist justifying the
authorization of the emergency use of personal respiratory protective devices during the
COVID-19 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



 2020年3月28日
致:未经NIOSH批准的进口一次性过滤面罩(呼吸器) 的制造商       卫生保健人员;   医院采购部门和分销商;
进口商和商业批发商;和   任何其他适用的利益相关者。

尊敬的利益相关者:
于2020年2月4日,依据《联邦食品,药品和食品安全法》第564(b)(1)(C)条,
化妆品法(该法)(《美国法典》第21卷§360bbb-3(b)(1)(C)),美国商务部部长
卫生与公共服务(HHS)确定存在突发公共卫生事件,
影响国家安全或美国健康与安全的巨大潜力
居住在国外的公民,并且涉及导致COVID-19的病毒。根据部分
该法第564条,并在此确定的基础上,HHS秘书随后宣布:
2020年3月2日,该情况证明有必要紧急使用
2019年冠状病毒病(COVID-19)期间的个人呼吸防护设备
爆发,但须遵守根据第1节发布的任何授权的条款

2020年3月24日,为了应对这种不断发展的公共卫生紧 急情况,
FDA得出过滤口罩呼吸器(FFR或呼吸器)短缺的结论
现有科学证据表明,某些未经NIOSH批准的进口一次性FFR适用于保护公众健康或安全(如第二节所述)
联邦食品,药品和化妆品法(该法)第564条规定的授权范围)
(《美国法典》第21卷第360bbb-3条)。

2020年3月28日,为进一步解决一次性 FFR的短缺问题, FDA认定
有必要重新发布2020年3月24日的信函,以修改授权范围
(第二节)额外授权使用已获得授权的呼吸器
根据授权的消毒系统的条款和条件进行消毒2。
 
1美国卫生与公共服务部,《公共卫生突发事件的确定与声明》
根据联邦食品,药品和食品安全局第564(b)条的规定,存在存在合理授权的情况
《美国化妆品法》(U.S.C. 21) §360bbb-3。 85 FR 7316(2020年2月4日)。美国卫生与人类部
服务,根据联邦第564条的规定,存在可以证明正当授权的情况,
美国法典第21卷《食品,药品和化妆品法》 §360bbb-3。 2020年3月2日。
2就本EUA而言,“授权去污系统”是指具有以下特征的任何去污系统:
已签发EUA。授权的消毒系统可在FDA的紧急使用授权中找到
网页,网址为:https: //www.fda.gov/emergency-preparedness-and-response/mcm-legal- regulatory-andpolicy-framework/emergency-use-authorization

第2页–非NIOSH批准的进口FFR的 利益相关者
得出结论认为,修订EUA适合保护公众健康或安全
根据该法第564(g)(2)(c)节(《美国法典》第21卷第360bbb-3(g)(2)(c)节),FDA将重新发布
2020年3月24日的全部信函及其修正案3
合并以授权
紧急使用:

1)附录1中列出的授权呼吸器可用于医疗机构:
根据CDC使用的医护人员(HCP)4
防止佩戴者接触致病性生物空气传播的建议
由COVID-19爆发引起的FFR短缺期间的微粒;和,

2)附件1中所列已消毒的授权呼吸器
根据授权的去污系统的条款和条件
根据CDC使用时,由HCP用于医疗机构
防止佩戴者接触致病性生物空气传播的建议
由COVID-19爆发引起的FFR短缺期间的颗粒物。
本EUA不影响先前的2020年3月2日EUA(于2020年3月27日重新发布,
再次于2020年3月28日生效),该法案部分授权紧急使用某些呼吸器
根据42 CFR Part 84,由NIOSH批准为无动力空气净化器
HCP用于医疗机构的颗粒FFR,以防止佩戴者接触致病菌
由COVID-19爆发引起的FFR短缺期间的空气中生物微粒,
根据该法令第564条。
得出结论认为,根据《专利法》第564(c)条的规定,该授权的发布标准
符合法案,我正在授权紧急使用授权的防毒面具,如
授权范围(第二部分)并根据授权条件(第二部分)
根据CDC的规定,由HCP在卫生保健机构中使用的本信函IV)
防止佩戴者接触致病性生物空气传播颗粒的建议

因COVID-19爆发而导致FFR短缺。
有关CDC关于优化呼吸器使用的最新建议,
有 关CDC关于优化呼吸器使用的最新建议,请访问CDC的
网 页:优化N95呼吸器供应的策略。本EUA不允许公 众使用授权的呼吸器。

一, 授权发布标准
我 得出的结论是,紧急使用授权呼吸器的范围如
该 信函授权(第二部分)由HCP用于医疗机构以防止佩戴者
 
3 2020年3月24日函件的2020年3月28日修正案修改了授权呼吸器的范围,包括
附 件1中列出的经过授权的呼吸器,已使用授权的消毒系统进行了消毒。

4医护人员是指在医疗机构中服务的所有有薪和无薪人员,他们有可能

直 接或间接接触患者或传染性物质,包括身体物质(例如血液,组织和特 定的体液);
受污染的医疗用品,设备和设备;受污染的环境表面;

或 被污染的空气。这些医疗保健人员包括但不限于紧急医疗服务
人 员,护士,护理助理,医师,技术人员,治疗师,采血医生,药剂师,牙医和
牙 科保健员,学生和实习生,非医疗保健机构雇用的合同人员以及
直 接参与患者护理,但可能暴露于可在患者体内传播的传染原
医 疗机构(例如,文书,饮食,环境服务,洗衣,安全,工程和设施管 理,行政,账单和志愿者人员。

第3页–非NIOSH批准的进口FFR的 利益相关者

FFR 短缺造成的FFR短缺期间暴露于病原性生物空气传播颗粒
COVID -19爆发符合《美国国家卫生法》第564(c)条规定的发布授权的标准
该 法案,因为我得出的结论是:

1. SARS-CoV-2(可导致COVID-19的病毒)可导致严重或危及生命
感 染这种疾病的人的疾病或状况,包括严重的呼吸道疾病病 毒;

2. 根据FDA可获得的全部科学证据,有理由相信
授 权的呼吸器可能有效防止HCP暴露于病原体
FFR 短缺期间的生物空气传播微粒,以及已知和潜在的
授 权呼吸器的好处,当用于防止HCP暴露于此类呼吸器中时
COVID -19期间FFR短缺期间的颗粒物超过已知的和潜在的
此 类产品的风险;和

3. 没有足够的,批准的和可用的替代方法来紧急使用某 些呼吸器,用于在FFR期间防止HCP暴露于此类颗粒
防 止疾病传播的短缺。5,6

二。 授权范围
根 据该法令第564(d)(1)条,我已经得出结论,本授权的范围是
仅 限使用表1中列出的授权呼吸器和授权呼吸器
附 件1中所列的已根据
授 权的消毒系统,由HCP根据建议在HCP的医疗环境中使用
CDC 可以防止穿戴者在FFR期间接触病原性空气传播的病原体
COVID -19爆发造成的短缺。
符 合本EUA资格的呼吸器
符 合以下两类标准的呼吸器有资格获得授权
根 据本节(授权范围(第二部分))中所述的EUA。呼吸器
符 合数字1和/或2中的资格标准,并且符合条款和条件
该EUA (授权条件(第IV部分))将根据
程 序概述如下。资格类别如下:

1. 设计,评估和验证满足特定要求的一次性FFR性 能标准并具有相应的可接受产品分类,
如 下:

5 该法令第564(c)(4)条并未规定其他发行标准。

6 没有经过NIOSH批准并满足FDA法规要求的FFR数量不足
以 满足美国医疗保健系统的需求。这些一次性呼吸器是常规患者不可或缺的一部分
关 心。向处于COVID-19响应最前沿的HCP提供与CDC一致的FFR
为 了减少HCP患病风险并增加其危险性,有必要提供指导和建议
愿 意为受影响的患者或怀疑患有COVID-19的患者提供护理。

第4页–非NIOSH批准的进口FFR的利益相关者
表 格1:  管 辖权7  性 能  标 准;  可 以接受    产 品  分 类;  标 准/指 导 文 件资料;  保 护  系 数≥10

澳 大利亚AS / NZS  1716: 2012 P3,P2 AS / NZS   1715: 2009   
巴西ABNT / NBR  
13698: 2011 PFF3,PFF2 Fundacentro   CDU 614.894 
欧 洲EN 149-2001 FFP3,FFP2 EN 529:2005是  日 本JMHLW-2000 DS / DL3  DS / DL2  JIS T8150:  2006 年 
韩 国KMOEL-2017-64特刊1  ST  KOSHA  指 南H-82-  2015 年 
墨 西哥NOM-116-2009  N100, P100,  R100, N99,  P99, R99,N95,  P95, R95  NOM -116是
2. 具有以下一种授权的上市FFR:
监 管辖区:
• 欧洲CE标志
• 澳大利亚治疗用品注册簿(ARTG)列入证明
• 加拿大卫生部执照
• 日本制药和医疗器械(PMDA)/卫生部
劳 动和福利(MHLW)
为 了作为本EUA的授权呼吸器被添加到附件1中,制造商
和/ 或进口商必须通过电子邮件向FDA发送进口非NIOSH意图的请求
符 合上述1和/或2要求的经批准的一次性呼吸器。的
制 造商或进口商应通过电子邮件发送要求获得本EUA授权的请求
FDA 在CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov上提供了以下信息,
这 将使FDA确定一次性呼吸器是否符合以下要求:
根 据本EUA作为授权呼吸器添加到表1中:
• 指定制造商,型号,销售授权/证书来自
另 一个代表他们行事的监管机构或合格评定机构
(包 括授权号(如果有)),合格证明(如果有),
 
  (7加拿大未列出,因为它允许自我声明为NIOSH或同等标准。)

第5页–非NIOSH批准的进口FFR的 利益相关者

产 品符合的适用性能标准以及任何适用的指 导文件。
•估计您计划在公共场合进口的呼吸器数量
健 康紧急情况,
•产品标签的副本。呼吸器必须至少遵守
授 权条件下条件  A和B中的标签要求
(第 四节)。
FDA 收到上述信息以及需要确认的所有其他信息后
概 述以下类别的进口一次性呼吸道的适用性
上 文中,FDA将把其授权呼吸器的使用情况通知制造商。
通过回复制造商或进口商的电子邮件,在本EUA中显示1。
授 权呼吸器

附 件1中列出的上述授权呼吸器,如本标签所述
信 件,经HCP授权在医疗机构中分发并用于医疗机构
符 合CDC在本EUA下的建议,尽管这些建议不符合要求
适 用联邦法律另有要求的某些要求。
此 外,表1中列出的授权呼吸器已使用以下设备进行了消毒:
经 授权的去污系统仍受本EUA的授权,可用于医疗保健
根 据授权的条款和条件使用时,由HCP进行设置
尽 管呼吸器制造商无需采取任何措施,但仍可以使用消毒系统
它 们不符合适用的联邦法律另行规定的某些要求的事实。
根 据该法令第564(d)(2)条,我得出结论认为,有理由相信
与 以下情况一致使用时,授权呼吸器的已知和潜在好处:
该 信函的授权范围(第二部分)超过了此类信函的已知和潜在风险产 品。
我 已经根据该法案的第564(d)(3)条得出结论,
FDA 可获得的证据,有理由相信授权呼吸器可能是
使 用时可有效防止HCP暴露于某些颗粒中以防止疾病传播
符 合本条的授权范围(第二节)
该 法案第564(c)(2)(A)条。
FDA 已经审查了可供FDA使用的科学信息,包括
支 持上面第一部分中描述的结论,并总结

2. 具有以下一种授权的上市FFR:
监 管辖区:
• 欧洲CE标志
• 澳大利亚治疗用品注册簿(ARTG)列入证明
• 加拿大卫生部执照
• 日本制药和医疗器械(PMDA)/卫生部
劳 动和福利(MHLW)
为 了作为本EUA的授权呼吸器被添加到附件1中,制造商
和/ 或进口商必须通过电子邮件向FDA发送进口非NIOSH意图的请求
符 合上述1和/或2要求的经批准的一次性呼吸器。的
制 造商或进口商应通过电子邮件发送要求获得本EUA授权的请求
FDA 在CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov上提供了以下信息,
这 将使FDA确定一次性呼吸器是否符合以下要求:
根 据本EUA作为授权呼吸器添加到表1中:
• 指定制造商,型号,销售授权/证书来自
另 一个代表他们行事的监管机构或合格评定机构
(包 括授权号(如果有)),合格证明(如果有),
 
7 加拿大未列出,因为它允许自我声明为NIOSH或同等标准。

第5 页–非NIOSH批准的进口FFR的利益相关者
产 品符合的适用性能标准以及任何适用的
指 导文件。 •估计您计划在公共场合进口的呼吸器数量
健 康紧急情况,•产品标签的副本。呼吸器必须至少遵守
授 权条件下条件A和B中的标签要求
(第 四节)。
FDA 收到上述信息以及需要确认的所有其他信息后
概 述以下类别的进口一次性呼吸道的适用性
上 文中,FDA将把其授权呼吸器的使用情况通知制造商。
通 过回复制造商或进口商的电子邮件,在本EUA中显示1。
授 权呼吸器
附 件1中列出的上述授权呼吸器,如本标签所述
信 件,经HCP授权在医疗机构中分发并用于医疗机构
符 合CDC在本EUA下的建议,尽管这些建议不符合要求
适 用联邦法律另有要求的某些要求。
此 外,表1中列出的授权呼吸器已使用以下设备进行了消毒:
经 授权的去污系统仍受本EUA的授权,可用于医疗保健
根 据授权的条款和条件使用时,由HCP进行设置
尽 管呼吸器制造商无需采取任何措施,但仍可以使用消毒系统
它 们不符合适用的联邦法律另行规定的某些要求的事实。
根 据该法令第564(d)(2)条,我得出结论认为,有理由相信
与 以下情况一致使用时,授权呼吸器的已知和潜在好处:
该 信函的授权范围(第二部分)超过了此类信函的已知和潜在风险产 品。
我 已经根据该法案的第564(d)(3)条得出结论,

FDA 可获得的证据,有理由相信授权呼吸器可能是
使 用时可有效防止HCP暴露于某些颗粒中以防止疾病传播
符 合本条的授权范围(第二节)
该 法案第564(c)(2)(A)条。
FDA 已经审查了可供FDA使用的科学信息,包括
支 持上面第一部分中描述的结论,并总结

FDA 已经审查了可供FDA使用的科学信息,包括
支 持以上第一部分所述的结论,并得出结论认为
呼 吸器,用于医疗机构时,以防止HCP暴露于某些颗粒
预 防疾病传播(如本函授权范围所述(第二部分)),
符 合该法第564(c)节中有关安全性和潜在性的标准效 力。
根 据本EUA紧急使用授权的呼吸器必须与并且
不 得超过本信函的条款,包括授权范围(第二部分)和

第6页–非NIOSH批准的进口FFR的 利益相关者
授 权条件(第四节)。
遵守本EUA的条款并根据
HHS 局长根据第564(b)(1)(C)条确定的情况
以 上所述以及HHS秘书根据第564(b)(1)条作出的相应声明,
根 据HCP的规定,HCP授权在医疗场所使用授权的呼吸器。

本EUA 的条款和条件。可以根据需要对EUA进行修订
,OST / CDRH,感染控制和塑料与重建事业部的同意
手 术/ CDRH和OCET / OCS / OC。
当HHS 声明存在情况证明其合理性时,此EUA将不再有效
根 据该法令第564(b)(2)条或根据该法撤销EUA时,终止EUA
该 法令第564(g)条。

三, 豁免某些FDA要求
我 放弃适用的现行良好生产规范要求,包括21 CFR Part 820中有关设计,制造,包装,
按 照以下说明使用的授权呼吸器的标签,存储和分发
此EUA。
IV。 授权条件
根 据该法令第564(e)条,我为此确定了以下条件
授 权:
授 权呼吸器制造商
A. 要求授权呼吸器的制造商公布其预期用途和其他
有 关导入的所有授权模型的说明(例如拟合测试等),以及
根 据本EUA在其网站上以英语授权。此外,制造商必须
通 过发送电子邮件至FDA的CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov通知FDA
符 合此条件的网站地址(URL)。 FDA将提供此信息
可 在其EUA网站上向公众公开,网址为
          https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe   
制 造商必须将此页面的任何更改通知FDA。
B. 除上述电子标签条件外,经授权的制造商 呼 吸器还需要包括一封英文信,该信可以分发
接 收授权呼吸器的每个最终用户设施(例如,每个医院等)模 型。这封信
必须包括授权呼吸器的制造商,型号,预期用途
使 用,制造商的网页(如果有)等。
C. 授权呼吸器的制造商应将以下情况通知进口商(如果适用):
此EUA 的条款和条件,并确保最终用户设施(例如,每家医院,接 收授权呼吸器的信息等)。
条 件B。

第7页–非NIOSH批准的进口FFR的 利益相关者

D. 授权呼吸器的制造商将有一个报告不良反应的流程到位
他 们意识到的事件并将此类报告发送给FDA。
E. 与在呼吸机中使用授权呼吸器有关的所有描述性印刷材料。
美 国应与适用的CDC建议保持一致,以用于COVID -19爆发以及本EUA中规定的条款。
F. 不得使用任何与授权呼吸器有关的描述性印刷品。
美 国可能代表或暗示该产品对以下方面是安全或有效的: 预 防COVID-19。
G. 授权呼吸器的制造商将确保与此相关的任何记录维 持EUA直到FDA另行通知。这样的记录将被制作
可 根据要求提供给FDA进行检查。
H. 经授权消毒的授权呼吸器制造商除 污系统对可能适用的任何其他条件概不负责
给 去污系统的制造商和/或运营商,除非他们是同 一制造商。

进 口商
I, 所有与使用授权呼吸器有关的描述性印刷材料应为与CDV 建议在COVID-19期间使用的建议一致
爆 发以及本EUA中规定的条款。

J. 不得使用与授权呼吸器有关的描述性印刷材料代 表或暗示该产品对于预防COVID-19是安全或有效的。

K. 授权呼吸器的进口商将条款和条件通知制造商此EUA, 并确保接收到的最终用户设施(例如,每家医院等)
授 权呼吸器还收到条件B要求的信息。

L.授权呼吸器的进口商应确保与此EUA相关的任何记录
维 持到本公共卫生紧急情况结束为止。
授 权消毒系统的制造商和/或运营商

M.认可的去污系统的每个制造商和/或经营者
授 权呼吸器的去污必须符合以下条件:
授 权书中规定的授权和授权标签授 权的去污系统。

必 须如本授权书所述紧急使用授权呼吸器
遵 守本授权的条件和所有其他条款。

第8页–非NIOSH批准的进口FFR的利益相关者

五, 授权期限
该EUA 将一直有效,直到宣布存在证明情况合理的理由为止。

授 权在使用过程中紧急使用个人呼吸防护设备
根 据该法案第564(b)(2)条,COVID-19爆发已终止,或者EUA被撤销根 据该法令第564(g)条的规定。

真 诚的
/ S /
____________________________
RADM 丹妮丝·辛顿
首 席科学家
食 品和药物管理局