NIOSH Conformity Assessment Letter

to Manufacturers

NIOSH CA 2021-1036

July 2021

 

Subject: Immediate Information for NIOSH-Approval Holders having Public 

Health Emergency (PHE) Approvals issued during the COVID-19 Response, 

and the forthcoming NIOSH revocation of these PHE approvals
Document Number

NIOSH CA 2021-1036

Page 2 of 4

1) SUMMARY

Throughout 2020, NIOSH issued limited, temporary Public Health Emergency (PHE) approvals for N95 

filtering facepiece respirators (FFRs) and powered air-purifying respirators (PAPRs). NIOSH is 

informing the holders of those PHE approvals about the forthcoming NIOSH revocation of these 

approvals. PHE approvals will be revoked upon expiration of the public health emergency 

declaration first issued by the HHS Secretary on January 31, 2020.

1

On April 9, 2021, CDC updated its “Strategies for Optimizing the Use of N95 Respirators.” These 

updates include an acknowledgement that the supply and availability of NIOSH-approved respirators 

have increased significantly over the last several months. The updates to the guidance as summarized 

on the CDC website include:

o For conventional capacity strategies

 Added language on extended use of N95 respirators as source control

 Added language on use of respirators with exhalation valves

o For contingency capacity strategies

 Added a strategy to prioritize respirators for healthcare personnel (HCP) who 

are using them as PPE over those HCP who are only using them for source 

control

 For extended use of N95 respirators as PPE, clarified that N95 respirators 

should be discarded immediately after being removed

o For crisis capacity strategies

 Removed the strategy of using non-NIOSH-approved respirators developed by 

manufacturers who are not NIOSH-approval holders

 Highlighted that the number of reuses should be limited to no more than five 

uses (five donnings) per device by the same HCP to ensure an adequate 

respirator performance

 Removed decontamination of respirators as a strategy with limited re-use

 Emphasized that facemasks for caring for a patient with suspected or 

confirmed SARS-CoV-2 infection should only be used for certain scenarios as a 

last resort if respirators are severely limited

1 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. 

Subject: Immediate Information for NIOSH-Approval Holders having Public Health 

Emergency (PHE) Approvals issued during the COVID-19 Response, and the 

forthcoming NIOSH revocation of these PHE approvals
Document Number

NIOSH CA 2021-1036

Page 3 of 4

 Removed the table “Suggested well-fitting facemask or respirator use, based

upon distance from a patient with suspected or confirmed SARS-CoV-2

infection and use of source control”

During the COVID-19 response, one crisis and contingency strategy included the use of NIOSHapproved FFRs and PAPRs identified as PHE Approvals. As described in each NIOSH PHE approval 

letter, the N95 FFR or PAPR PHE approval was granted and effective on a limited and temporary basis. 

In anticipation of the end of the declared public health emergency and the concomitant revocation of 

the PHE approvals, if the PHE approval holder intends to provide a smooth transition for PHE respirator 

users, the PHE approval holder may submit a new approval application to obtain a conventional NIOSH

approval. An application for a new NIOSH approval must be submitted and approved by NIOSH through 

the respirator approval process described in 42 CFR Part 84, NIOSH Conformity Assessment Notice

NIOSH CA 2021-1034R1, and the NIOSH Standard Application Procedures.

The table below provides a summary of the FDA, NIOSH, and OSHA dispositions regarding NIOSH PHE 

approvals. The agencies continue to collaborate to establish post-COVID-19 solutions to optimize the 

respiratory protection options available in healthcare settings during conventional operations. 

Respirator 

Type

PRE-COVID PHE USE DURING COVID PHE USE POST-COVID PHE USE

FDA NIOSH OSHA FDA NIOSH OSHA FDA NIOSH OSHA

PHE N95 FFR PHE devices did not exist   X X X

PHE PAPR    X X X

2) AUTHORITY

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

3) REFERENCES

Letter from RADM Denise M. Hinton, FDA, to Dr. Robert Redfield, CDC, March 11, 2020, to clarify 

Emergency Use Authorization (“EUA”) issued by the Food and Drug Administration (“FDA”) on March 2, 

2020

Letter from RADM Denise M. Hinton, FDA, to Dr. Robert Redfield, CDC, March 28, 2020, authorizing 

emergency use of NIOSH-approved air-purifying respirators for use in healthcare settings by HCP to 

prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting 

from the Coronavirus Disease 2019 (COVID-19) outbreak, pursuant to Section 564 of the Federal Food, 

Drug, and Cosmetic Act (the Act) (21 U.S.C. § 360bbb-3)

Authorization for Medical Products for Use in Emergencies, 21 U.S.C. § 360bbb-3
Document Number

NIOSH CA 2021-1036

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

NIOSH Conformity Assessment Notice (CA 2021-1034R1), June 2021, Summarized information about 

NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance 

Requirements and (iii) Supplier or Subcontractor Agreements

Standard Application Procedure for the Approval of Air-Purifying Filtering Facepiece Respirators Under 

42 CFR Part 84, revised March 12, 2018, Section 3.1 and 3.2

Standard Application Procedure for the Approval of Powered Air-Purifying Respirators and Chemical, 

Biological, Radiological and Nuclear Powered Air-Purifying Respirators Under 42 CFR Part 84, revised 

March 12, 2018, Section 3.1 and 3.2