Under the provisions of 42 CFR 84, NIOSH is authorized to approve respirators. The regulatory specifications include performance requirements as well as the criteria for the quality assurance program relevant to manufacturing respirators. In an average year, NIOSH receives approximately 400 requests and grants 250 new approvals.
In the approval process, NIOSH first conducts an initial engineering review to ensure that the request for certification matches all of the accompanying documentation, including product drawings and the quality assurance system specifications.
The product is then sent to the laboratory for testing, and concurrently the National Institute for Occupational Safety and Health (NIOSH) conducts a quality assurance review that delves into the manufacturing processes and procedures. A final review includes comparing the manufacturer’s test results with those obtained by NIOSH’s laboratory and finalizing the labeling, which then leads to an issued approval.
In order to receive a manufacturer’s code, NIOSH/NPPTL (National Personal Protective Technology Laboratory) will need a Manufacturer’s Questionnaire completed and returned by the entity that controls the design or manufacturing of the respirator.
Completed questionnaire must include a photo of the facility showing the company name on the building, a photo of the quality assurance area, and a photo of the production line.
NIOSH will issue a certificate of approval for individual, completely assembled respirators which have been examined, inspected, and tested, and which meets the minimum requirements set forth in subparts H through L, as applicable.
- Each application for approval must contain a complete written description of the respirator for which approval is requested, together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used.
- Drawings must be titled, numbered, and dated.
- Proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part.
- A statement that the respirator has been pretested by the applicant as prescribed in § 84.64, and must include the results of such tests.
- A statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing.
24/7 Live Chat is available, for your convenience.
NIOSH will not issue a certification of a surgical N95 respirator until FDA confirms it is also reviewing the product.
An individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator may apply to NIOSH to become an approval holder.
- Organizations may appoint an authorized representative to complete and submit the Standard Application Form (SAF) to NIOSH.
- Prospective approval holders, who have received a three character manufacturer’s code, may submit an initial application for a single new respirator along with a signed and approved company Quality Assurance (QA) Manual.
NIOSH User Fees are extra and required.
These fees are paid to the U.S. Treasury, for the examination, inspection, and testing of respirators, which are submitted to NIOSH for the purpose of obtaining or modifying a certificate of approval.
Application-Based Fees
Fee type
Application
Legal citation
42 CFR 84.20(b)(1)
Amount
$200 per application submitted.
Due Date
Upon receipt of any application request.
Fee type
Approval
Legal citation
42 CFR 84.20(b)(1)
Amount
$100 per each certificate of approval issued.
Due Date
Upon completion of the application and granting of an approval number.
Fee type
Approval Modification
Legal citation
42 CFR 84.20(b)(1)
Amount
$50 per each certificate of approval modified.
Due Date
Upon agreement on the date of the site qualification examination.
Fee type
Site Qualification
Legal citation
42 CFR 84.20(b)(3)
Amount
- Existing approval holder, paper review:
$400 per each request to inspect new production facility. - Non-approval holders:
- Domestic site visit—$2,500
- International site visit—$7,500
Due Date
Upon completion of the application and issuing a modified approval.
Annual (Fixed) Fees
Fee type
Maintenance of Product Performance (product audit)
Legal citation
42 CFR 84.20(b)(5)
Amount
- Annual fee: $761 per each approval holder
- Variable fee: As billed by NIOSH based on the respirators chosen to be tested each year
Due Date
- Upon billing from NIOSH
- October
Fee type
Records Maintenance
Legal citation
42 CFR 84.20(b)(1)
Amount
$50 for all listed approvals on file with NIOSH on July 1st of each year.
Due Date
- Upon billing from NIOSH
- October
Fee type
Quality Assurance Maintenance (site audit)
Legal citation
42 CFR 84.20(b)(4)
Amount
- Annual fee: $3,000 per every manufacturing site registered with NIOSH.
- Variable fee:
- 1 day domestic audit—$2,500 per site
- 2 day domestic audit—$5,000 per site
- 1 day international audit—$7,500 per site
- 2 day international audit—$10,000 per site
Due Date
- Upon billing from NIOSH
- October
Fee type
Maintenance of Testing and Approval Facilities
Legal citation
42 CFR 84.20(b)(2)
Amount
$34 per every listed approval on file with NIOSH on July 1st of each applicable year.
Due Date
- Upon billing from NIOSH
- October
Fee type
Maintenance of Test Equipment
Legal citation
42 CFR 84.20(b)(2)
Amount
$36 per every listed approval on file with NIOSH on July 1st of each applicable year.
Due Date
- Upon billing from NIOSH
- October
NIOSH other User Fees are related to products testing, and vary from $75.00 to $22,000.00 each for:
- Air-Purifying Respirators
- Air-Supplied Respirators
- Chemical, Biological, Radiologic, Nuclear (CBRN) Air-Purifying and Air-Supplied Respirators
Early in the public health emergency, there was a need to issue emergency use authorizations (EUAs) for non-NIOSH-approved respirators as well as decontamination and bioburden reduction systems to disinfect disposable respirators.
Since the beginning of the pandemic, NIOSH has approved more than 875 respirator models or configurations, with some of these manufactured by approximately 20 new, domestic NIOSH-approval holders. There are more than 6,400 total respirator models or configurations on the NIOSH-certified equipment list which have met the NIOSH-approved EUA criteria and thus are FDA-authorized. These include:
- 600 filtering facepiece respirator (FFR) models (of which there are over 530 N95 FFR models)
- 5,500 elastomeric respirator configurations, including new elastomeric respirators without an exhalation valve
- 360 powered air purifying respirator configurations
Today, those conditions no longer exist because of an increase in domestically-manufactured NIOSH-approved N95s available throughout the country. As a result, the FDA revoked Emergency Use Authorizations (EUAs) of all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, which includes imported disposable respirators such as N95s and KN95s.
Occupational Safety and Health Administration’s (OSHA) recently published Emergency Temporary Standard (ETS) requires health care employers to provide NIOSH-approved or FDA-authorized respirators.
Therefore, domestic and foreign companies need to stop importing or exporting non-NIOSH-approved respirators.
NIOSH-approved filtering facepiece respirators (FFRs) will always have one of the following designations: N95, N99, N100, R95, R99, R100, P95, P99, P100.
Signs that a respirator may be counterfeit:
- No markings at all on the filtering facepiece respirator
- No approval (TC) number on filtering facepiece respirator or headband
- No NIOSH markings
- NIOSH spelled incorrectly
- Presence of decorative fabric or other decorative add-ons (e.g., sequins)
- Claims for the of approval for children (NIOSH does not approve any type of respiratory protection for children)
- Filtering facepiece respirator has ear loops instead of headbands
Any misuse of NIOSH marks, including on respirators that have failed to satisfy NIOSH’s regulatory requirements or have not received a NIOSH approval, is a direct violation of trademark laws.
