Briefing Summary: US FDA Posts Advisory Committee Materials About Blood Donor Policies Involving MSM, BECS Software, Ebola and Chikungunya and MERS-CoV Virus Infections – DEC 2-3, 2014 (BPAC)
On December 2, 2014, the Committee will meet in open session to hear scientific data related to reconsideration of the current blood donor deferral policy for men who have had sex with another man (MSM) even one time since 1977. The Committee will be presented with an update on the November 13, 2014, meeting of the U.S. Department of Health and Human Services Advisory Committee on Blood and Tissue Safety and Availability where the MSM blood donor deferral policy will be discussed. In the afternoon, the Committee will hear an informational presentation on Ebola virus, the potential implications for blood safety in the United States and FDA’s considerations on the collection of convalescent plasma for investigational use.
On December 3, 2014, the Blood Products Advisory Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of blood establishment computer software (BECS) and accessories to BECS. Blood establishment computer software is currently subject to the premarket notification (510(k)) provisions of the Federal Food, Drug, and Cosmetic Act. In the afternoon, an informational presentation will be made regarding the emergence of chikungunya virus infections in the Western Hemisphere and potential implications for blood transfusion safety. The Committee will also hear an informational presentation on the first survey of the Rapid Donor Surveillance (RapidDOS) project on Middle Eastern Respiratory Syndrome coronavirus (MERS-CoV).