May 7, 2020

NIOSH Is Prioritizing New Respirator Approval Applications

In response to the COVID-19 pandemic, NIOSH has informed respirator manufacturers that the agency’s Respirator Approval Program is prioritizing particulate filtering respirator approval applications submitted by existing approval holders and new domestic respirator manufacturers or applicants. The agency stated that its action is intended to increase the supply of NIOSH-approved particulate filtering respirators.

Priority will be given to applications related to approval for filtering facepiece respirators, half-mask and full-facepiece air-purifying respirators, and powered air-purifying respirators. The agency’s action supersedes a February 2020 communication indicating that NIOSH would prioritize applications to increase the supply of N95 FFRs.

NIOSH is not accepting applications for approval of FFRs with ear loops or other novel head suspensions for the duration of the pandemic response.

Approved respirators will be added to the NIOSH Certified Equipment List, a searchable database that allows users to identify respirators appropriate for protecting against specific hazards. Once added to the Certified Equipment List, respirators will be covered under the Food and Drug Administration’s March 28 letter (PDF) approving emergency use in healthcare settings of respirators originally intended for general use.

Instructions for manufacturers on how to apply for NIOSH respirator approval are available on the agency’s website.