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N95 Respirators: EUA Conditions for State and/or Local Public Health Authority(ies)

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As described in the Food and Drug Administration (FDA) final guidance entitled “Emergency Use Authorization of Medical Products” (dated July 2007), Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act, or “the Act”) requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an EUA authorization that the Commissioner finds necessary or appropriate to protect the public health, and permits the Commissioner to establish other conditions that he finds necessary or appropriate to protect the public health.

Pursuant to section 564 of the Act, the following conditions have been established for state and/or local public health authority(ies) regarding the emergency use of certain N95 Respirators1:

State and/or Local Public Health Authority(ies):

  • Will make available through appropriate means the authorized Summary Fact Sheet [89.8KB]
  • Will ensure that authorized N95 respirators are distributed to recipients in accordance with applicable state and local laws and/or in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to deliver, distribute, or dispense the covered countermeasures, and their officials, agents, employees, contractors, or volunteers following a declaration of an emergency.
  • Are authorized to make available additional information relating to the emergency use of authorized N95 respirators that is consistent with, and does not exceed, the terms of this letter of authorization.
  1. The FDA has authorized for the emergency use of certain personal respiratory protection devices deployed from the Strategic National Stockpile. The specific products covered are listed in the EUA Summary Fact Sheet [89.8KB] and the FDA-issued EUA Authorization letter [2.41MB].

For any questions regarding EUA conditions, please contact EUA.OCET@fda.hhs.gov.

 
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