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U.S. Department of Health and Human Services

Medical Devices

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Letter of Amendment: Emergency Use of Disposable N95 Respirators from Strategic National Stockpile

The information previously contained on these webpages were authorized under the 2009 H1N1 Influenza Emergency Use Authorizations (EUAs). As of June 23, 2010, the EUAs have been terminated and this information is no longer current.

May 1, 2009

Richard E. Besser, MD
Acting Director
Centers for Disease Control and Prevention
1600 Clifton Rd., MS D-14
Atlanta , GA 30333

Dear Dr. Besser:

As you know, on April 27, 2009, I issued a letter authorizing the emergency use of certain personal respiratory protection devices, specifically disposable respirators certified by the National Institute for Occupational Safety and Health, with a minimum filtration efficiency classification of N95. I hereby amend that letter to clarify the term “general public” is broad and includes people performing work-related duties. In addition, I hereby amend the letter and the Summary Fact Sheet to clarify that the authorization affects only requirements applicable under the Federal Food, Drug, and Cosmetic Act. The revised authorization letter is attached.

 

____________________________

Joshua M. Sharfstein, MD
Principal Deputy Commissioner
Acting Commissioner

Attachment

  1. Letter of Authorization: Emergency Use of Disposable N95 Respirators from Strategic National Stockpile