NIOSH Conformity Assessment Letter

 to Manufacturers

 NIOSH CA 2021-1032

February 2021

 

Subject: Effective Immediately – In response to COVID-19 – Updated NIOSH 

fraud and fraudulent statements policy and prioritization for accepting and 

examining particulate filtering respirator approval applications, including 

Surgical N95 respirators, submitted by existing domestic and non-domestic 

approval holders, new domestic manufacturers/applicants, and new nondomestic manufacturers/applicants.

Supersedes NIOSH CA 2020-1031
Document Number

NIOSH CA 2021-1032

Page 2 of 5

NIOSH issued an earlier version of this Conformity Assessment Letter to Manufacturers (CA 2020-1031) 

in August 2020 to address the overwhelming number of new applications submitted to the NIOSH 

Respirator Approval Program as well as the serious and ongoing attempts to defraud the Program. 

The February 2021 version of this Letter provides new guidance on fraud and fraudulent statements.

The February 2021 version of this Letter also updates the prioritization order for accepting and 

examining particulate filtering respirator approval applications and clarifies NIOSH’s definitions of 

“domestic manufacturer” and “non-domestic manufacturer.” 

FRAUD AND FRAUDULENT STATEMENTS

If the NIOSH Respirator Approval Program determines, at any time, that an applicant1 or a third party 

acting on behalf of the applicant has engaged in any of the following:

• making any materially false, fictitious, or fraudulent statement or representation, including 

any omission or concealment of substantive fact in any application or application-related 

material or communication; or

• misrepresenting or misusing the NIOSH manufacturers’ code, respirator approval number, or 

NIOSH title or logo,

the NIOSH Respirator Approval Program will discontinue the processing of any current application for 

a certificate of approval from the applicant for the duration of the HHS COVID-19 public health 

1 “Applicant” means an individual, partnership, company, corporation, association, or other organization that designs, 

manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such 

respirator. See 42 C.F.R. § 84.2.

Subject: Effective Immediately – In response to COVID-19 – Updated NIOSH fraud 

and fraudulent statements policy and prioritization for accepting and examining 

particulate filtering respirator approval applications, including surgical N95 

respirators, submitted by existing domestic and non-domestic approval holders, 

new domestic manufacturers/applicants, and new non-domestic 

manufacturers/applicants.

Supersedes NIOSH CA 2020-1031
Document Number

NIOSH CA 2021-1032

Page 3 of 5

emergency declaration first issued on January 31, 20202 and will not process any new application for a 

certificate of approval from the applicant for that same time period.

Information concerning suspected fraud related to the NIOSH Respirator Approval Program will be 

reported to the Department of Health and Human Services Office of Inspector General (OIG). Any 

person who knowingly and willfully makes any false statement, misrepresentation, concealment of 

fact, or any other act of fraud to obtain any benefit from the NIOSH Respirator Approval Program is 

subject to civil and/or administrative remedies as well as felony criminal prosecution and may, under 

appropriate criminal provisions, be punished by a fine or imprisonment or both pursuant to 18 U.S.C. § 

1001.

Additionally, due to ongoing, heightened concerns over counterfeiting, NIOSH will not respond to 

emails that lack recognizable company domains. Examples include emails that look like 

3894876@hotnet.net, cv2009@vip.126.com, or 3273865@qq.com. NIOSH will only respond to 

inquiries concerning an approval application or request from an email address recognizably associated 

with a legitimate business or stakeholder.

APPLICATION PRIORITY

In response to the nation’s effort to control the spread of COVID-19, the NIOSH Respirator Approval 

Program is accepting and prioritizing applications received for new approvals and extension of 

approvals submitted by existing approval holders (both domestic and non-domestic manufacturers) 

and new domestic respirator manufacturers/applicants.

NIOSH considers domestic respirator manufacturers to be those whose design/development activities, 

quality assurance activities, and manufacturing sites are located inside the United States. 

Manufacturers whose headquarters are located within the United States but whose 

design/development activities, quality assurance activities, and manufacturing sites are not within the 

United States are considered by NIOSH to be non-domestic manufacturers.

NIOSH is committed to protecting healthcare personnel and all workers who rely on NIOSH-approved 

respirators by accepting and expediting applications to increase the supply of NIOSH-approved 

particulate filtering (air-purifying) respirators and ensure quality products providing the intended 

protections are available. Accordingly, NIOSH is prioritizing applications seeking or modifying approval 

for filtering facepiece respirators (FFRs), including half mask and full facepiece air-purifying respirators 

2 See https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx for the most current Renewal of the 

Determination that a Public Health Emergency Exists Nationwide as the Result of the Continued Consequences of 

Coronavirus Disease 2019 (COVID-19) Pandemic. 
Document Number

NIOSH CA 2021-1032

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(APRs), powered air-purifying respirators (PAPRs), and Surgical N95 FFRs described in NIOSH CA 2018-

1010R1. Manufacturers/approval holders interested in applying for Surgical N95 FFR approval MUST 

follow the guidance in NIOSH CA 2018-1010R1 and should expect approval timelines based on the 

order described below.

For the duration of the current HHS COVID-19 public health emergency declaration, NIOSH is not 

accepting applications for approval of APRs (including FFRs) with novel head suspensions, e.g., ear 

loops. NIOSH is focusing its resources to approve designs with traditional two head-strap suspensions, 

commonly used in respirator designs demonstrating the fit and protection required by OSHA.

Effective immediately and including applications accepted by NIOSH prior to publication of this notice, 

NIOSH will prioritize applications in the order described below:

1. Domestic approval holders submitting a new or an extension application, including a new or 

extension application using the SN95 Guidance. NOTE: This does NOT include claims about 

barrier performance based on ASTM F2100-20, Standard Specification for Performance of 

Materials Used in Medical Masks, or claims exceeding the threshold limitations defined in 

the NIOSH/FDA MOU.

2. Domestic and non-domestic approval holders submitting Quality Assurance (QA) 

applications to facilitate FFR, APR, and PAPR production at additional manufacturing sites, in 

accordance with established and NIOSH-approved QA systems.

3. New domestic applicants. NOTE: NIOSH has developed procedures to conduct virtual 

domestic site qualification evaluations of new domestic manufacturing and quality 

management facilities for applicants seeking their first NIOSH approval for an FFR, APR, or 

PAPR. Alternatively, NIOSH may use a contractor to conduct the site qualification visit.

4. Non-domestic approval holders submitting a new application using the SN95 Guidance. 

NOTE: This does NOT include claims about barrier performance based on ASTM F2100-20, 

Standard Specification for Performance of Materials Used in Medical Masks, or claims 

exceeding the threshold limitations defined in the NIOSH/FDA MOU.

5. New domestic applicants re-submitting a new application after a prior denial was issued by 

NIOSH. NIOSH has developed procedures to conduct virtual domestic site qualification 

evaluations of new domestic manufacturing and quality management facilities, for applicants 

seeking their first NIOSH approval for an FFR, APR, or PAPR. Alternatively, NIOSH may use a 

contractor to conduct the site qualification visit.
Document Number

NIOSH CA 2021-1032

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6. Non-domestic approval holders submitting a new or extension application.

7. New non-domestic applicants submitting a new application using the SN95 Guidance, with 

priority given to products manufactured in Canada and Mexico. Timelines will depend on the 

ability to arrange and complete initial site qualification visits. NOTE: This does NOT include 

claims about barrier performance based on ASTM F2100-20, Standard Specification for 

Performance of Materials Used in Medical Masks, or claims exceeding the threshold 

limitations defined in the NIOSH/FDA MOU.

8. New non-domestic applicants, with priority given to products manufactured in Canada and 

Mexico. Timelines will depend on the ability to arrange and complete initial site qualification 

visits.

9. New non-domestic applicants re-submitting a new application after a prior denial was issued 

by NIOSH. Timelines will depend on the ability to arrange and complete initial site 

qualification visits.

Once NIOSH-approved, the respirators will be added to the NIOSH Certified Equipment List and will 

thus be covered under the FDA’s clarification letter and Emergency Use Authorization (EUA), dated 

March 28, 2020 for use by healthcare personnel.

Requests for new manufacturer codes and other questions related to the NIOSH Respirator Approval 

Program from non-domestic manufacturers with no previous relationship to the Program will be 

answered as NIOSH resources allow.