Respirator Approval: How to Apply

At a glance

This webpage provides information on how to apply for respirator approval. All applicants must meet the regulatory requirements stated in 42 Code of Federal Regulations Part 84 to become NIOSH approval holders.

For Manufacturers - How to apply for NIOSH Respirator Approval document cover.

NIOSH approval process

When seeking your first NIOSH approval, you must take several steps before submitting your product for NIOSH approval as described in this booklet.

Flow chart showing the step-by-step process to obtain NIOSH approval.
First time applicant steps to obtaining NIOSH approval.

These steps include:

  • Answering a questionnaire to assess an applicant's readiness to apply for NIOSH approval
  • Obtaining a NIOSH manufacturer code
  • Ensuring that an applicant understands and has completely prepared all the required documentation in advance

NIOSH expects that, prior to submitting an application, an applicant will have all the required elements of the production process in place. Use the same quality management system that the applicants describe within the application package.

  1. The first step in the approval process is for the entity that controls the design or manufacturing of the respirator to request a Potential Applicant Questionnaire from RecordsRoom@cdc.gov.
  2. After completing this questionnaire, NIOSH will review the information provided. If the responses are satisfactory, NIOSH will assign a 3-letter manufacturer code. This code does not imply NIOSH approval. However, applicants must obtain this code before submitting a formal respirator approval request.
  3. Next NIOSH will send you the Standard Application Form to submit a single approval request for a new respirator. All required documentation (as listed on page 6 within the booklet), test samples, and appropriate fees, as detailed in the Standard Application Procedures, must be provided. Links to the Standard Application Procedures are below.
  4. When an application is accepted for review, NIOSH assigns it a task number. NIOSH will then review the application and test the product in accordance with Standard Testing Procedures.

Note

NIOSH approval is not guaranteed. Any respirators produced prior to receiving your NIOSH approval should not be assumed to be acceptable. Therefore, production quantities should be carefully considered until the approval is finalized.

Quality assurance review

While there are many parts of the overall NIOSH review process, the quality assurance review may present the biggest challenge for new applicants. NIOSH will evaluate your quality management system (QMS) to ensure you have the processes in place to maintain the quality of your respirators. This review will include a site visit, referred to as a site qualification, to any location in which manufacturing and QMS activities are specified.

As part of the site qualification, NIOSH will verify that specific quality documents, such as inspection procedures, including classification of defects (see ), the sampling plan, and sampling levels have been fully and correctly used. Applicants should review NIOSH CA 2019-1019 and NIOSH CA 2021-1034R1 for guidance on NIOSH's review process.

Know Before You Apply: Summarized Quality Requirements Needed to Achieve NIOSH Approval
Overview of the NIOSH approval process and the application package requirements.

Noteworthy notices for new applicants

  1. CA 2019-1012 - NIOSH Respirator Approval Contents and Meaning
  2. CA 2019-1019 - Effective Immediately – NIOSH quality control plan requirements
  3. CA 2021-1034R1 - Summarized Information about NIOSH Respirator Approval Program
    1. Basic Application Procedures
    2. Quality Assurance Requirements
    3. Supplier or Subcontractor Agreements
  4. CA 2023-1061 - Effective Immediately – NIOSH Respirator Approval Program Returns to Conventional Operations

Related pages

Person writing on a checklist.
Conformity Assessment Notices
Collection of NIOSH Conformity Assessment Notices and Letters.
Individual at computer with graphics of documents in front of them. Checking boxes on one of the documents.
Standard Application Procedures
Standard Application Procedures for each class of respirator.
Image of a pen and checklist
Statement of Standards for Respirators with CBRN Protections
This page includes statement of standards for respirators with CBRN protections.
Stack of checklists with green check marks and a dollar sign in the corner
Respirator Certification Fees and Standard Test Procedures
Provides respirator certification fee tables and corresponding Standard Test Procedures.
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Content Source:
; National Institute for Occupational Safety and Health