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