Respirator Approval Information

Updated September 3, 2020

How to apply for NIOSH Respirator Approval

NIOSH is prioritizing applications as described in the Conformity Assessment Letter to Manufacturers, NIOSH CA 2020 -1031. During the response, it may take longer to respond to requests for a new manufacturers code or to provide the additional information about the NIOSH Respirator Approval Program’s application procedures.

The first step in the approval process is for the entity that controls the design or manufacturing of the respirator to request a Manufacturer’s Questionnaire from RecordsRoom@cdc.gov.

After completing this questionnaire, NIOSH will review the information provided and, if the responses are satisfactory, assign a 3-letter manufacturer code. This code does not imply NIOSH approval; however, you must obtain this code before you can submit a formal respirator approval request.

Once you obtain a manufacturer code, NIOSH will send you the Standard Application Form to submit a single approval request for a new respirator. All required documentation (including the Quality Manual), test samples and appropriate fees, as detailed in the Standard Application Procedures must be provided. Links to the Standard Application Procedures are below.

All new applicants should read through the NIOSH Conformity Assessment Notices prior to submitting an application to become more familiar with the process.

Fees

Respirator Certification Fees Final Rule effective May 26, 2015

Respirator Certification Fees, Questions, and Answerspdf icon [PDF – 126 KB], June 15, 2015

Fees for Chemical Warfare Agent (CWA) Testing Portion of Chemical, Biological, Radiological, and Nuclear (CBRN) Approval, effective September 1, 2014

Logos

DHHS, NIOSH, and CBRN Logos for use by approval holders on labels for NIOSH-approved respirators.

NIOSH-Approved Chemical, Biological, Radiological, and Nuclear Agents (CBRN) Logopdf icon [PDF – 9 KB]

Standard Testing Procedures

Standard Testing Procedures (STPs)
Each respirator and component submitted for approval must meet the applicable requirements outlined in 42 CFR Part 84 subparts H through L. The standard testing procedures used by NIOSH are listed in this section.

Other Information

Policy Supporting the Collection of NIOSH Approval Feespdf icon [PDF – 58 KB]
This policy document is intended to provide specific implementation guidance and interpretation to support fee collections in accordance with the requirements of Title 42 Code of Federal Regulations (42 C.F.R.), Part 84, Subpart C–Fees.

Long-term Field Evaluation Policypdf icon [PDF – 69 KB]
This policy document is intended to clarify the application of Title 42 Code of Federal Regulations (42 CFR) § 84.310, “Post-approval testing,” paragraph (c), by offering a more precise explanation of the tests the National Institute for Occupational Safety and Health (NIOSH) expects to perform in fulfillment of this requirement.

Colors for Respirator Element Labeling, dated January 17, 2008
The color coding requirements of labels for canisters and cartridges as a means for secondary identification.

Respirator Certification Program Decision Review Processpdf icon [PDF – 593 KB], dated January 30, 2008
A structured process that enables stakeholders to request a review of decisions regarding NPPTL policy statements, test procedures, and test results pertaining to ongoing respirator certification activities.

Page last reviewed: September 3, 2020