N95口罩FDA认证EUA要求

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April 3, 2020
To: Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece
Respirators;
Health Care Personnel;
Hospital Purchasing Departments and Distributors;
Importers and Commercial Wholesalers; and
Any Other Applicable Stakeholders.
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 April 3, 2020, in response to this evolving public health emergency and continued concerns
about filtering facepiece respirator (FFR or respirator) availability, FDA concluded based on the
totality of scientific evidence available that certain product classifications for imported
disposable FFRs that are manufactured in China and not NIOSH-approved and for which data
exists that supports the respirators’ authenticity, 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). Under this EUA, authorized
respirators listed in Appendix A are authorized for use in healthcare settings by healthcare
personnel (HCP)2 when used in accordance with CDC recommendations to prevent wearer

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 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 2 – Stakeholders for Non-NIOSH-Approved Imported FFRs Made in China
exposure to pathogenic biological airborne particulates during FFR shortages resulting from the
COVID-19 outbreak.
This EUA does not affect the previous March 28, 2020, EUA for Non-NIOSH-Approved
Imported FFRs (originally issued on March 24, 2020), which authorizes, in part, the emergency
use of certain imported disposable FFRs that are not NIOSH-approved and excluded those
manufactured in China, 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. FDA is issuing this EUA to authorize disposable respirators manufactured in
China that meet certain criteria, including additional validation and review by FDA to confirm
the respirator’s authenticity.
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 pandemic.
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
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 and other information 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
Page 3 – Stakeholders for Non-NIOSH-Approved Imported FFRs Made in China
3. There is no adequate, approved, and available alternative to the emergency use of the
authorized respirators for preventing HCP exposure to such particulates during FFR
shortages to prevent disease spread.
3,4
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 Appendix A, and includes authorized
respirators that have been decontaminated pursuant to the terms and conditions of an authorized
decontamination system,5
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
A disposable non-NIOSH-approved respirator manufactured in China that meets one of the
following criteria for authentication is eligible for authorization under this EUA:
1. It is manufactured by an entity that holds one or more NIOSH approvals for other
models of FFRs produced in accordance with the applicable standards of authorization
in other countries that can be verified by FDA;
2. It has a regulatory authorization under a jurisdiction other than China that can be
authenticated and verified by FDA; or
3. It demonstrates acceptable performance to applicable testing standards as documented
by test reports from a recognized independent test laboratory that can be verified by
FDA.
6
A respirator that meets the eligibility criteria outlined above will be added to Appendix A as an
authorized respirator once FDA confirms the criteria for issuance are met. FDA may ask a
manufacturer that is requesting authorization for any additional information FDA needs to
confirm the respirator is eligible under one of the criteria outlined above.