NIOSH Requirements for N95 masks

Industry UPDATE: NIOSH Requirements for N95 masks

In response to the nation’s effort to control the spread of COVID-19, the NIOSH Respirator Approval Program is accepting and prioritizing applications received for new approvals and extension of approvals submitted by existing approval holders (both domestic and non-domestic manufacturers) and new domestic respirator manufacturers/applicants.

NIOSH considers domestic respirator manufacturers to be those whose design/development activities, quality assurance activities, and manufacturing sites are located inside the United States.

Manufacturers whose headquarters are located within the United States but whose design/development activities, quality assurance activities, and manufacturing sites are not within the United States are considered by NIOSH to be non-domestic manufacturers.

Effective immediately and including applications accepted by NIOSH prior to publication of this notice, NIOSH will prioritize applications in the order described below:

1. Domestic approval holders submitting a new or an extension application, including a new or extension application using the SN95 Guidance. NOTE: This does NOT include claims about barrier performance based on ASTM F2100-20external icon, Standard Specification for Performance of Materials Used in Medical Masks, or claims exceeding the threshold limitations defined in the NIOSH/FDA MOUexternal icon.
2. Domestic and non-domestic approval holders submitting Quality Assurance (QA) applications to facilitate FFR, APR, and PAPR production at additional manufacturing sites, in accordance with established and NIOSH-approved QA systems.
3. New domestic applicants. NOTE: NIOSH has developed procedures to conduct virtual domestic site qualification evaluations of new domestic manufacturing and quality management facilities for applicants seeking their first NIOSH approval for an FFR, APR, or PAPR. Alternatively, NIOSH may use a contractor to conduct the site qualification visit.
4. Non-domestic approval holders submitting a new application using the SN95 Guidance. NOTE: This does NOT include claims about barrier performance based on ASTM F2100-20external icon, Standard Specification for Performance of Materials Used in Medical Masks, or claims exceeding the threshold limitations defined in the NIOSH/FDA MOUexternal icon.
5. New domestic applicants re-submitting a new application after a prior denial was issued by NIOSH. NIOSH has developed procedures to conduct virtual domestic site qualification evaluations of new domestic manufacturing and quality management facilities, for applicants seeking their first NIOSH approval for an FFR, APR, or PAPR. Alternatively, NIOSH may use a contractor to conduct the site qualification visit.
6. Non-domestic approval holders submitting a new or extension application.
7. New non-domestic applicants submitting a new application using the SN95 Guidance, with priority given to products manufactured in Canada and Mexico. Timelines will depend on the ability to arrange and complete initial site qualification visits. NOTE: This does NOT include claims about barrier performance based on ASTM F2100-20external icon, Standard Specification for Performance of Materials Used in Medical Masks, or claims exceeding the threshold limitations defined in the NIOSH/FDA MOUexternal icon.
8. New non-domestic applicants, with priority given to products manufactured in Canada and Mexico. Timelines will depend on the ability to arrange and complete initial site qualification visits.
9. New non-domestic applicants re-submitting a new application after a prior denial was issued by NIOSH. Timelines will depend on the ability to arrange and complete initial site qualification visits.

Click on the link below for the NIOSH Conformity Assessment Letter to Manufacturers, which has been updated as of February 2021.  The letter provides new guidance on fraud and fraudulent statements.  It also updates the prioritization order for accepting and examining particulate filtering respirator approval applications and clarifies NIOSH’s definitions of “domestic manufacturer” and “non-domestic manufacturer.”
https://www.cdc.gov/niosh/npptl/resources/pressrel/letters/conformitymanuf/CA-2021-1032.html