The National Institute for Occupational Safety and Health (NIOSH) has updated the NIOSH Respirator Approval Program, cutting approval timelines by more than one-third and expanding enforcement actions to remove counterfeit respirators from the marketplace. The changes are intended to improve access to certified respiratory protection while reinforcing confidence in NIOSH approval markings across regulated industries.
The NIOSH Respirator Approval Program is the federal system used to evaluate and certify respirators against defined performance, quality assurance, and reliability standards. Approved respirators are used across healthcare, emergency response, industrial, and research settings where workers face airborne chemical, biological, or particulate hazards.
Approval integrity is critical because respirators that lack certification or ongoing oversight may not deliver the level of protection users expect. Products that fail to meet performance requirements can expose workers to hazards and undermine respiratory protection programs, procurement controls, and regulatory compliance efforts.
NIOSH Respirator Approval Program reduces certification timelines
NIOSH reported measurable improvements in the respirator approval process over the past year. In 2024, the average application processing time for respirator approvals was 100 days. From mid-May 2025 through the present, that average declined to 65 days, representing a 35 percent reduction.
The agency attributed the faster timelines to streamlined internal workflows, cross-training of staff, and expanded technical assistance for applicants. Earlier communication between NIOSH and manufacturers allows potential approval holders to clarify requirements and resolve technical issues before certification is delayed.
Shorter approval timelines help stabilize the supply of NIOSH-approved respirators, particularly during periods of elevated demand or supply chain disruption. Faster certification also supports the introduction of new respirator models and updated configurations into the market.
Growth in approved respirator configurations
As approval efficiency improved, NIOSH increased the number of certified products available. In 2025, the agency granted 528 new respirator approvals.
These approvals included 140 new self-contained breathing apparatus configurations equipped with chemical, biological, radiological, and nuclear protections. While many of these systems support firefighting and emergency response, the expanded approval volume reflects greater overall capacity within the respirator approval program.
A broader portfolio of approved respirators gives organizations more flexibility to select protection aligned with specific exposure risks, operational needs, and emergency preparedness requirements.
Increased oversight to combat counterfeit respirators
NIOSH emphasized that the program extends beyond initial certification. Ongoing oversight includes factory audits, quality system reviews, and off-the-shelf testing to confirm that approved products continue to meet certification requirements while on the market.
Counterfeit respirators and products that misrepresent approval status remain a persistent risk. These products may misuse certification marks such as N95, P100, or “NIOSH Approved,” creating a false sense of protection for users.
NIOSH reported investigating 4,163 potentially fraudulent online respirator listings. Since May 2025, the agency identified 1,245 fraudulent listings, including 260 found on high-visibility online marketplaces. These investigations resulted in 189 product removals.
What the updated respirator approval process means for safety programs
The latest changes to the NIOSH Respirator Approval Program reinforce several priorities for organizations that rely on respiratory protection:
- Confirm respirators carry legitimate NIOSH approval markings and documentation
- Use authorized suppliers and avoid listings without traceable approval information
- Integrate ongoing product verification into respiratory protection program oversight
- Ensure workers receive training on proper respirator use and fit
By accelerating approvals while strengthening market surveillance, NIOSH aims to improve access to certified respiratory protection and reduce the circulation of counterfeit respirators, reinforcing trust in the respirator approval process across regulated workplaces.
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This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
