NIOSH Conformity Assessment Letter

to Manufacturers

NIOSH CA 2020-1027

April 2020

 

Subject: Effective Immediately - In response to COVID-19 - NIOSH is 

accepting and prioritizing particulate filtering respirator approval 

applications submitted by existing approval holders and new domestic 

manufacturers/applicants

Supersedes NIOSH CA 2020-1024
Document Number

NIOSH CA 2020-1027

Page 2 of 3

In response to the nation’s effort to control the spread of coronavirus disease 2019 (COVID-19) 

outbreak, the National Institute for Occupational Safety and Health (NIOSH) Respirator Approval 

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

approvals submitted by existing approval holders and new domestic respirator 

manufacturers/applicants. 

NIOSH is committed to protecting healthcare personnel and Americans preparing to return to work 

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. The applications accepted can include those seeking or modifying approval for filtering 

facepiece respirators (FFR), half mask and full facepiece air-purifying respirators (APR) and powered 

air-purifying respirators (PAPR). During the response, NIOSH is not accepting applications for 

approval of FFRs with novel head suspensions, e.g. ear loops. 

Once 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.

NIOSH is also prioritizing Quality Assurance (QA) applications to facilitate FFR, APR, and PAPR 

production at additional manufacturing sites, in accordance with established and NIOSH-approved QA 

systems. 

NIOSH is also developing 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.

The prioritization of domestic requests will impact NIOSH’s ability to process requests received from

new international respirator manufacturer for manufacturers codes, application and engineering

reviews and related questions. Additionally, due to heightened concerns over counterfeiting, NIOSH 

will not respond to emails that lack recognizable company domains. Examples include emails that look 

like 3894634876@hotnet.net, or cv2009@vip.126.com, or 3272523865@qq.com. Inquiries for 

approval will only be responded to when received from an email address recognizably associated with 

a legitimate business or stakeholder.

Subject: Effective Immediately - In response to COVID-19 - NIOSH is accepting and 

prioritizing particulate filtering respirator approval applications submitted by 

existing approval holders and new domestic manufacturers/applicants

 
Document Number

NIOSH CA 2020-1027

Page 3 of 3

Supplemental Information

FDA EUAs NOT Associated with NIOSH Approved Respirators 

The FDA Emergency Use Authorizations website should be checked for the most up-to-date 

information. As of April 23, 2020, the FDA has issued three EUA’s that do NOT require seeking NIOSH 

approval, NIOSH asks stakeholders interested in inclusion in these authorizations read and follow the 

information and guidance provided by the FDA.

For inclusion in Exhibit 1 Authorized Respirators:

Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators; 

https://www.fda.gov/media/136403/download March 28, 2020, Imported other than China 

For inclusion in Appendix A:

Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators;

https://www.fda.gov/media/136664/download April 3, 2020, Imported China 

Manufacturers of Face Mask:

https://www.fda.gov/media/137121/download April 18, 2020, Facemasks, non-surgical