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Respirator Approval Information

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How to apply for NIOSH Respirator Approval

Know Before You Apply
Cover page for fact sheet 2023-132

The National Institute for Occupational Safety and Health (NIOSH) Respirator Approval Program frequently receives questions from manufacturers, distributors, and designers related to NIOSH respirator approval applications. Frequently, NIOSH is not able to approve an application because achieving NIOSH approval requires implementing a robust quality management system in addition to meeting performance requirements. This booklet provides an overview of the NIOSH approval process and the application package requirements to address the most frequently asked questions, deter inappropriate applications, and better prepare potential NIOSH approval holders for the application process.

Read this Booklet

NIOSH has returned to conventional operations in relation to respirator approval applications. Please see NIOSH Conformity Assessment Letters to Manufacturers, NIOSH CA 2023-1061, for more information about application prioritization.

Applicants should review NIOSH CA 2021-1034R1 for guidance on NIOSH’s review process.

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, applicants 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.

NIOSH 42 CFR Part 84, Approval of Respiratory Protective Devices
This rule addresses NIOSH approval requirements for respiratory protective devices.

Standard Application Procedures (SAP)

NOTE: Applicants should review the entire document and contact the Records Room at RecordsRoom@cdc.gov or 412-386-4000 with any questions before submitting a respirator for approval.

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 Answers [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

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 Fees [PDF – 58 KB]
This policy document provides 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 Policy [PDF – 69 KB]
This policy document clarifies 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
This guidance provides the color-coding requirements of labels for canisters and cartridges as a means for secondary identification.