NIOSH Conformity Assessment Letter to

Manufacturers

NIOSH CA 2023-1061

July 2023

 

Subject: Effective Immediately—NIOSH Respirator Approval Program 

Returns to Conventional Operations.

This notice supersedes NIOSH CA 2022-1040
Document Number

NIOSH CA 2023-1061

Page 2 of 4

This notice applies to applications submitted to the National Institute for Occupational Safety and 

Health (NIOSH) for approval under the Respirator Approval Program, 42 C.F.R. Part 84. Due to 

increased demand and decreased supply of NIOSH Approved® respirators during the COVID-19 Public 

Health Emergency (PHE), NIOSH prioritized applications for the approval of air-purifying particulate 

filtering respirators. The COVID-19 PHE, declared under Section 319 of the Public Health Service (PHS) 

Act, expired on May 11, 2023, and the supply and availability of this type of NIOSH Approved 

respirators have increased significantly since the PHE was originally declared. Therefore, effective 

immediately, NIOSH is returning to conventional operations and will no longer prioritize respirator 

approval applications by type of respirator. 

CONVENTIONAL APPLICATION PROCESSING

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

NIOSH is returning to conventional operations and is reviewing applications accordingly, regardless of 

the type of respiratory protection for which the applicant is seeking approval. NIOSH encourages 

approval holders and applicants to review the application order described below. 

Application Order: 

1) Approval holders submitting a new application or an application for an extension of approval 

for any type of respiratory protection, including air-purifying and atmosphere (air)-supplying 

protections. Quality Assurance 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. Applications to request correlation testing remain the 

lowest priority for NIOSH.

2) New respirator applicants submitting their first application. 

Subject: Effective Immediately—NIOSH Respirator Approval Program Returns to 

Conventional Operations. 

This notice supersedes NIOSH CA 2022-1040
Document Number

NIOSH CA 2023-1061

Page 3 of 4

3) New respirator applicants re-submitting their first application after a prior denial was issued by 

NIOSH. 

The timeline for completing the review of a new respirator applicant request for approval will 

depend on the resources available to conduct the initial site qualification visit. NIOSH is conducting 

in-person or virtual site qualification evaluations of an applicant’s manufacturing and quality 

management facilities when English is the primary language used at those facilities. NIOSH will 

begin to conduct in-person site qualification evaluations of an applicant’s manufacturing and 

quality management facilities, where English is NOT the primary language, as resources allow, and 

NIOSH may use a third party to conduct the site qualification visit.

NIOSH reminds approval holders and applicants that air-purifying particulate respirator applications

that include a novel head suspension, e.g., ear loops, will not be accepted. The Respirator Approval 

Program does not presently have a defined performance standard against which to assess devices with 

novel head suspensions. As indicated in the Fall 2022 Unified Agenda, NIOSH intends to incorporate a 

new performance standard into Part 84 to allow NIOSH to test the fit characteristics of non-powered, 

air-purifying, particulate respirators during the approval process; however, those efforts remain 

ongoing.

Applicants and approval holders interested in applying for NIOSH Surgical N95® filtering facepiece 

respirator approval should follow the guidance in NIOSH CA 2018-1010R1.0 and should expect the 

application review to begin based on the information provided above. 

N95 and NIOSH Approved are certification marks of the U.S. Department of Health and Human Services (HHS) registered in the United 

States and several international jurisdictions.
Document Number

NIOSH CA 2023-1061

Page 4 of 4

AUTHORITY and REFERENCES

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

Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap | HHS.gov

COVID-19: Renewal of Determination that a Public Health Emergency Exists (hhs.gov)

NIOSH Conformity Assessment Letter to Manufacturers (CA 2018-1010R1.0) | 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

Fall 2022 Unified Agenda, Respirator Fit Capability Test Standard, Filter Shelf Life, and Application 

Requirements for Air-Purifying Particulate Respirators