NIOSH Conformity Assessment Letter

to Manufacturers

NIOSH CA 2022-1040

February 2022

 

Subject: Effective Immediately - Prioritization of applications submitted by 

existing domestic approval holders and new domestic applicants for new 

approvals or extensions-of-approval for particulate filtering respirators,

including Surgical N95 respirators. This prioritization does not include 

private-label requests. 

This notice and NIOSH CA 2022-1041 supersede NIOSH CA 2021-1032
Document Number

NIOSH CA 2022-1040

Page 2 of 5

NIOSH CA 2021-1032, a Conformity Assessment Letter to Manufacturers (Letter) published in February 

2021, offered prioritization guidance to address the overwhelming number of new applications 

submitted to the NIOSH Respirator Approval Program (Program) throughout 2020 and early 2021. In 

that Letter, the Program continued to prioritize applications seeking or modifying approval for half and 

full facepiece particulate filtering air-purifying respirators (APRs), including filtering facepiece 

respirators (FFRs), and powered air-purifying respirators (PAPRs) produced in the United States. The 

prioritization included domestic Surgical N95 FFRs (SN95s) applications described in NIOSH CA 2018-

1010R1. The February 2021 letter also included a new policy prohibiting fraud and fraudulent 

statements in the application process. 

The February 2021 Letter is superseded by this notice, NIOSH CA 2022-1040 (prioritization guidance), 

and NIOSH CA 2022-1041 (fraud and fraudulent statements). 

This February 2022 Letter is updated to clarify that NIOSH will continue to prioritize applications for 

particulate filtering APRs (full and half facepiece), including FFRs, SN95s, and PAPRs, produced in the 

United States, with preference to domestic approval holders and new domestic applicants. NIOSH 

continues prioritizing applications submitted by existing approval holders since in the Program’s 

experience existing approval holders are more likely to achieve and maintain approvals. However, 

applications from existing approval holders to offer private-label versions of a NIOSH-approved 

respirator will not be prioritized since this process does not increase the capacity of the approval 

holder to make and release NIOSH-approved respirators. 

NIOSH will continue prioritizing the addition of manufacturing sites for all existing approval holders. 

This can increase the supply of all types of NIOSH-approved respirators, with or without particulate

only protections. The process for adding sites requires two steps: 1) identifying the new location, 

typically accomplished using a quality assurance (QA) application; and 2) submitting an extension-forapproval application for the NIOSH-approved respirator(s) to be manufactured at the newly added 

manufacturing site. 

Subject: Effective Immediately - Prioritization of applications submitted by existing 

domestic approval holders, and new domestic applicants for approvals or 

extensions-of-approval for particulate filtering respirators, including Surgical N95 

respirators. This prioritization does not include private-label requests.

This notice and NIOSH CA 2022-1041 supersede NIOSH CA 2021-1032
Document Number

NIOSH CA 2022-1040

Page 3 of 5

The Program is not accepting applications for approval of APRs (including FFRs) with novel head 

suspensions, e.g., ear loops. NIOSH is focusing its resources on approving designs with traditional two 

head-strap suspensions, commonly used in respirator designs demonstrating the fit and protection 

required by Occupational Safety and Health Administration. Until NIOSH regulations in 42 C.F.R. Part 84

are updated to incorporate ASTM F3407-21, Standard Test Method for Respirator Fit Capability for 

Negative Pressure Half-Facepiece Particulate Respirators, into Subpart K, the Program does not have a 

defined performance standard against which to assess devices with novel head suspensions. NIOSH has 

indicated that plans to incorporate ASTM F3407-21 into Part 84, Subpart K are underway.

APPLICATION PRIORITY

NIOSH continues to focus on protecting healthcare personnel and all workers who rely on NIOSHapproved respirators during the COVID-19 Response by accepting and expediting applications to 

increase the supply NIOSH-approved particulate filtering respirators. Accordingly, NIOSH is prioritizing 

applications for new approvals and extension-of-approvals (except for private-label requests) for half 

and full facepiece APRs, including FFRs, SN95s, and PAPRs. Applicants and approval holders interested 

in applying for NIOSH Surgical N95 FFR approval MUST follow the guidance in NIOSH CA 2018-1010R1

and should expect approval timelines based on the order described below. NIOSH continues to 

prioritize QA application to increase an approval holder’s production capacity. 

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

notice, NIOSH will prioritize applications in the order described in items 1-9 below, with priority given 

to domestic approval holders and new domestic applicants: 

Domestic respirator applicants are those whose design/development activities, quality assurance 

activities, purchasing, and manufacturing sites are ALL located within the United States. 

Domestic approval holders are those whose corporate headquarters and some or all manufacturing 

are located within the United States and have achieved at least one NIOSH respirator approval. Private 

label assignees located within the United States are not approval holders since the NIOSH approval is 

achieved and maintained by the approval holder. Private label assignees are those with a contractual 

relationship with the approval holder. This allows them to sell the NIOSH respirators manufactured

and labeled for them by the approval holder. The approval holder indicates that they are a private 

label assignee in the user instructions. 

Non-Domestic respirator applicants are those whose headquarters or other activities, such as design 

and development activities, quality assurance activities, purchasing, or manufacturing are completed 
Document Number

NIOSH CA 2022-1040

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outside of United States. Within this notice, NIOSH does not consider those with headquarters only 

within the United States to be domestic applicants. They are considered non-domestic applicants. 

1. Domestic approval holders submitting a new or an extension application (except for 

private-label requests) for an FFR, APR, PAPR, or SN95.

2. Any approval holder submitting a QA application to facilitate production at an additional 

manufacturing site, in accordance with established and NIOSH-approved QA systems. QA 

applications to add manufacturing sites located in countries with U.S. Department of State 

travel advisories may not be approved due to the difficulty in conducting site visits in those 

countries. 

3. New domestic applicants submitting their first application (new) for an FFR, APR, PAPR, or 

SN95. NOTE: NIOSH is conducting virtual domestic site qualification evaluations of new 

domestic manufacturing and quality management facilities for applicants seeking their first 

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

visit.

4. New domestic applicants re-submitting a new application for an FFR, APR, PAPR, or SN95

after a prior denial was issued by NIOSH. NIOSH is conducting virtual domestic site 

qualification evaluations of new domestic manufacturing and quality management facilities, 

for applicants seeking their first NIOSH approval. Alternatively, NIOSH may use a contractor 

to conduct the site qualification visit or may conduct the site qualification using federal 

employees.

5. Non-domestic approval holders submitting a new or extension application (except for 

private-label requests) for an FFR, APR, PAPR, or SN95.

6. New non-domestic applicants submitting their first application (new) for an FFR, APR, PAPR,

or SN95 with priority given to products manufactured in Canada and Mexico. Timelines will 

depend on the ability to arrange and complete initial site qualification visits. 

7. New non-domestic applicants, re-submitting a new application for an FFR, APR, PAPR, or 

SN95 after a prior denial was issued by NIOSH, with priority given to products manufactured 

in Canada and Mexico. Timelines will depend on the ability to arrange and complete initial 

site qualification visits.

8. Approval holders submitting a request for a new or extension application for other types of 

respiratory protection not directly related to the COVID-19 Response, e.g., air-supplied 

respirators and respirators that protect against chemical, biological, radiological, and 

nuclear (CBRN) hazards.
Document Number

NIOSH CA 2022-1040

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9. Approval holders submitting a request for an extension of approval to offer a private-label 

versions of a NIOSH approved respirator. 

Once NIOSH-approved, new approvals will be added to the NIOSH Certified Equipment List. 

Respirators that offer particulate only protections will continue to be covered under the Food and Drug 

Administration’s clarification letter and Emergency Use Authorization (EUA), dated July 12, 2021 for 

use by healthcare personnel.

Requests for new manufacturer codes, and other questions related to the Program from non-domestic 

applicants with no previous relationship to the Program, will be answered as NIOSH resources allow.

REFERENCES

Approval of Respiratory Protective Devices, 42 C.F.R. Part 84

NIOSH Conformity Assessment Letter to Manufacturers (CA 2020-1030) | NPPTL | NIOSH | CDC

ASTM International, Standard Test Method for Respirator Fit Capability for Negative-Pressure HalfFacepiece Particulate Respirators, F3407-21.

NIOSH Science Blog, Overview of the ASTM F3407 Standard Test Method for Respirator Fit Capability.

The Development of Regulatory Requirements for Respirator Fit Capability Test Standards for AirPurifying, Half-Facepiece Particulate Respirators RIN 0920-AA77.