April 24, 2020

To: Manufacturers of Face Masks;

Health Care Personnel; 

Hospital Purchasing Departments and Distributors; and

Any Other Stakeholders.

On April 18, 2020, in response to concerns relating to insufficient supply and availability of face 

masks,

1,2 the U.S. Food and Drug Administration (FDA) issued an Emergency Use 

Authorization (EUA) authorizing the use of face masks for use by members of the general 

public, including health care personnel (HCP)

3 in healthcare settings as personal protective 

equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease 

Control and Prevention (CDC) recommendations, to prevent the spread of the virus called severe 

acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the Coronavirus Disease 2019 

(COVID-19) pandemic, pursuant to section 564 of the Federal, Food, Drug, and Cosmetic Act 

(the Act) (21 U.S.C. 360bbb-3).

On February 4, 2020, pursuant to Section 564(b)(1)(C) 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 

 1 A face mask is a device, with or without a face shield, that covers the user’s nose and mouth and may or may not 

meet fluid barrier or filtration efficiency levels. It includes cloth face coverings as a subset. It may be for single or 

multiple uses, and if for multiple uses it may be laundered or cleaned. There are many products marketed in the 

United States as “face masks” that offer a range of protection against potential health hazards. Face masks are 

regulated by FDA when they meet the definition of a “device” under section 201(h) of the Act. Generally, face 

masks fall within this definition when they are intended for a medical purpose. Face masks are regulated under 21 

CFR 878.4040 as Class I 510(k)-exempt devices (non-surgical masks). 2 Surgical masks are not covered within the scope of this authorization. Surgical masks are masks that cover the 

user’s nose and mouth and provide a physical barrier to fluids and particulate materials and are regulated under 21 

CFR 878.4040 as class II devices requiring premarket notification. Additionally, these masks meet certain fluid 

barrier protection standards and Class I or Class II flammability tests. More information on the distinction is 

provided in FDA guidance, titled “Enforcement Policy for Face Masks and Respirators During the Coronavirus 

Disease (COVID-19) Public Health Emergency” available at https://www.fda.gov/media/136449/download. 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).
Page 2

citizens living abroad, and that involves the virus that causes COVID-19.4 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, due to shortages during 

the COVID-19 pandemic, subject to the terms of any authorization issued under that section.5

On April 24, 2020 in response to questions and concerns that have been received by FDA since 

issuance of the April 18, 2020 letter of authorization and having concluded that revising the 

April 18, 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 April 18, 2020 

letter in its entirety with amendments6 incorporated. Specifically, FDA is clarifying through this 

re-issued letter that facemasks, including cloth face coverings, are authorized to be used by HCP 

only as source control7,8 in accordance with CDC recommendations under this EUA.

9 As stated 

in the April 18 letter, face masks are authorized for use by the general public to cover their noses 

and mouths, in accordance with CDC recommendations. 

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 face masks for use in accordance with CDC 

recommendations, as described in the Scope of Authorization (Section II) and pursuant to the 

Conditions of Authorization (Section IV) of this letter. 

For the most current CDC recommendations on the use of face masks by the general public 

during COVID-19, please visit CDC’s webpage: Recommendation Regarding the Use of Cloth 

Face Coverings, Especially in Areas of Significant Community-Based Transmission For the most 

recent recommendations on use of face masks by HCPs in a healthcare setting, see: Strategies to 

Optimize the Supply of PPE and Equipment.

I. Criteria for Issuance of Authorization

I have concluded that the emergency use of face masks in accordance with CDC 

recommendations as source control as described in the Scope of Authorization (Section II) to 

 4 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 7, 2020) 5 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

(March 27, 2020). 6 The amendments to the April 18, 2020 letter clarify that the eligible facemasks are to be used for source control

only, and are not personal protective equipment, meaning they are not a substitute for filtering face piece respirators

or for surgical face masks. This reissued EUA does not change any aspects of the April 18, 2020 letter with respect 

to the use of face masks by the general public.

7 Source control refers to the use of a facemask or cloth face covering over the mouth and nose to contain that 

individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have 

symptoms of COVID-19. 8 https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html 9 In addition, health care employers should refer to standards of the Occupational Safety and Health Administration 

(OSHA) that apply to PPE to protect workers and infectious disease hazards. See 29 CFR 1910 subpart I.
Page 3

help prevent spread of the virus 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 authorized face masks may be effective as source control to help prevent the spread of

SARS-CoV-2 by infected individuals who may or may not have symptoms of COVID-19

during the COVID-19 pandemic, and that the known and potential benefits of face masks, 

when used in accordance with the scope of this authorization (Section II), outweigh the 

known and potential risks of such product; and

3. There is no adequate, approved, and available alternative to the emergency use of face masks

for source control by the general public and for HCPs to help prevent the spread of the virus

due to face mask shortages during the COVID-19 pandemic.

10,11

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 face masks, including cloth face coverings, as source control for use by 

members of the general public, as well as HCP in healthcare settings, to cover their noses and 

mouths, in accordance with CDC recommendations, to help prevent the spread of the SARSCoV-2 during the COVID-19 pandemic. The facemasks are not intended to be used by HCPs as 

PPE, meaning they are neither substitutable for respiratory protective devices such as filtering 

face piece respirators, nor for surgical face masks. This use is consistent with face masks 

regulated as Class I 510(k)-exempt face masks under 21 CFR 878.4040.

Authorized Face Masks

Face masks are authorized under this EUA when they are intended for use as source control, by 

members of the general public as well as HCPs in healthcare settings, to cover their noses and 

mouths, in accordance with CDC recommendations, to help prevent the spread of SARS-CoV-2 

during the COVID-19 pandemic. Authorized face masks must meet the following requirements:

1. The product is labeled accurately to describe the product as a face mask and includes a 

list of the body contacting materials (which does not include any drugs or biologics);

 10 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act. 11 Providing authorization for the introduction into interstate commerce of face masks by manufacturers that do not 

customarily engage in the manufacture of medical devices helps meet the needs of the healthcare system. In 

addition, increased availability of face masks helps meet the needs for source control for the general population,

reserving FDA-cleared surgical masks and FDA-cleared or -authorized N95 and N95 equivalent Face Filtering 

Respirators for use by HCP. Providing HCP who are on the forefront of the COVID-19 response with sufficient 

PPE is necessary in order to help prevent HCP exposure to pathogenic biologic airborne particulates during the

COVID-19 pandemic.
Page 4

2. The product is labeled accurately so that it does not claim to be intended for use as a 

surgical mask or to provide liquid barrier protection;

3. The product labeling includes recommendations against use in a clinical setting where the 

infection risk level through inhalation exposure is high;

4. The product is not labeled in such a manner that would misrepresent the product’s 

intended use; for example, the labeling must not state or imply that the product is 

intended for antimicrobial or antiviral protection or related uses or is for use such as 

infection prevention or reduction;

5. The product is not labeled as a respiratory protective device, and therefore should not be 

used for particulate filtration; and

6. The product is not labeled for use in high risk aerosol generating procedures.

12

Manufacturers of face masks that are used as described above and meet the above requirements 

(i.e., are within this section (the Scope of Authorization, Section II)) do not need to take any 

action, other than complying with the Conditions of Authorization (Section IV) to be authorized 

under this EUA. FDA’s posting and public announcement of this EUA at 

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policyframework/emergency-use-authorization, serves as face mask manufacturers’ notification of 

authorization.

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 face masks as described within this section (the Scope of 

Authorization, 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 face masks may be effective as 

described within this section (the Scope of Authorization, Section II) of this letter, 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 of this letter, and concludes that face masks (as 

described in this section, 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 face masks 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 and conditions 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), face masks, as source 

control, are authorized for use by members of the general public, as well as HCPs in healthcare 

settings, to cover their noses and mouths, in accordance with CDC recommendations, to help 

prevent the spread of SARS-CoV-2 during the COVID-19 pandemic. 

 12 Examples of aerosol generating procedures in healthcare settings may be found at 

https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-faq.html
Page 5

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 practice otherwise applicable to the manufacture, processing, packing, or holding 

of products subject to regulations under this Act, including such requirements established under 

sections 520(f)(1). FDA grants that waiver, including the quality system requirements under 21 

CFR Part 820 and labeling requirements under the FD&C Act and FDA regulations, including 

unique device identification requirements in 21 CFR Part 830 and 21 CFR 801.20, except that 

face masks must include the labeling elements specified in the Conditions of Authorization

(Section IV).

IV. Conditions of Authorization

Pursuant to Section 564(e) of the Act, I am establishing the following conditions to this 

authorization:

Manufacturers and Distributors of Authorized Products13

A. Manufacturers and Distributors will make face masks available with labeling that 

includes a description of the product as a face mask, including a list of the body 

contacting materials (which does not include any drugs or biologics).

B. Manufacturers and Distributors of authorized products shall not label the product: 1) 

as a surgical mask, to provide liquid barrier protection; 2) for use in a clinical setting 

where the infection risk level through inhalation exposure is high; 3) for antimicrobial 

or antiviral protection or related uses or uses for infection prevention or reduction or 

related uses; 4) as a respiratory protective device; or 5) for high risk aerosolgenerating procedures. 

C. Manufacturers must make the required labeling available to each end user or end user 

facility (each hospital) in hard copy or in an alternative format (e.g., electronic 

labeling on the manufacturer’s website). Instructions on how to access the labeling if 

provided in an alternative format must be available to each end user or end user 

facility. 

D. Manufacturers and Distributors will include instructions for recommended cleaning 

and/or disinfection materials and processes, if applicable, for their authorized 

product(s). Manufacturers must provide these instructions, if applicable, to each end

user or end user facility (e.g., each hospital) in hard copy or in an alternative format 

(e.g., electronic instructions). Instructions on how to access the labeling if provided in 

an alternative format must be available to each end user or end user facility.

 13 The requirements under 21 CFR Part 806 (Reports of Corrections and Removals) and 21 CFR Part 807 

(Registration and Listing) do not apply to products authorized under an EUA. As such, compliance with these 

regulations are not required under this EUA.
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E. Manufacturers will have a process in place for reporting adverse events of which they 

become aware to FDA under 21 CFR Part 803. Adverse events of which the 

manufacturer becomes aware will be reported to FDA. See FDA’s webpage “Medical 

Device Reporting (MDR): How to Report Medical Device Problems”14 for reporting 

requirements and procedures.15

F. Manufacturers and distributors 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.

G. Through a process of inventory control, manufacturers and distributors will maintain 

records of the entities to which they distribute the face masks and the numbers of 

each such product they distribute.

H. Manufacturers and distributors are 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.

Conditions Related to Advertising and Promotion 

I. All printed matter, including advertising and promotional materials, relating to the 

use of the authorized face mask shall be consistent with the labeling elements listed in 

Section II of this EUA, as well as the terms set forth in this EUA and the applicable 

requirements set forth in the Act and FDA regulations.

J. No printed matter, including advertising or promotional materials, relating to the use 

of the authorized face mask may represent or suggest that such product is safe or 

effective for the prevention or treatment of patients during the COVID-19 pandemic.

K. All advertising and promotional descriptive printed matter relating to the use of the 

product shall clearly and conspicuously state that

• The product has not been FDA cleared or approved

• The product has been authorized by FDA under an EUA for use as source 

control by the general public as well as by HCP in healthcare settings as to 

help prevent the spread of infection or illness during the COVID-19 

pandemic.

• This product is authorized only for the duration of the declaration that 

circumstances exist justifying the authorization of the emergency use of 

medical devices, including alternative products used as medical devices, 

 14 FDA guidance, titled “Medical Device Reporting (MDR): How to Report Medical Device Problems” is available 

at https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medicaldevice-problems. 15 Also refer to FDA guidance, titled “Postmarketing Adverse Event Reporting for Medical Products and Dietary 

Supplements During a Pandemic” available at https://www.fda.gov/media/72498/download. 
Page 7

during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C.

§ 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.

V. Duration of Authorization

This EUA will be effective until the declaration that circumstances exist justifying this

authorization 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