CDC H1N1 Flu | Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices

Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices
Site last updated June 24, 2010 10:00 AM ET


Per the FDA-issued advance notice letters listed below, the declaration of Public Health Emergency determination for 2009 H1N1 Influenza expired on June 23, 2010.

•Termination of Declarations of Emergency Justifying EUA of Certain Antiviral Drugs: Tamiflu (oseltamivir phosphate), Relenza (zanamivir), and Peramivir •Termination of Declaration of Emergency Justifying the Authorization of Emergency Use of Certain Personal Respiratory Protection Devices •Termination of Declaration of Emergency Justifying EUA of Certain In Vitro Diagnostic Tests

Information regarding Termination and Disposition of CDC-requested and FDA-issued EUA Products:
Antiviral Drugs:
•Relenza (zanamivir) and Tamiflu (oseltamivir)
◦Disposition Letter for Relenza and Tamiflu ◦Attachment 1 to the Disposition Letter for Relenza and Tamiflu: Questions and Answers Regarding Termination of the Emergency Use Authorizations (EUAs) for Tamiflu (oseltamivir) and Relenza (zanamivir) ◦Attachment 2 to the Disposition Letter for Relenza and Tamiflu:Update regarding Stockpiled Antivirals at or Nearing Expiration •Peramivir IV
◦Disposition Letter for Peramivir IV ◦Attachment to the Disposition Letter for Peramivir: Questions and Answers for Hospitals and Healthcare Professionals Regarding Termination of the Emergency Use Authorization (EUA) for Peramivir IV Devices:
•N95 Respirators
◦Disposition Letter for Certain Personal Respiratory Protection Devices Authorized for Emergency Use For questions regarding EUAs, contact: EUA.OCET@fda.hhs.gov

open here to see the documents from CDC:
CDC H1N1 Flu | Termination of the Emergency Use Authorization (EUA) of Medical Products and Devices