Zdrowie i gospodarka · 26.06.2003
Draft “Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Revised Recommendations for Donor and Product Management Based on Screening Tests for Syphilis" dated June 2003. The draft guidance document provides recommendations for testing donors of blood and blood components for syphilis, and for recommended actions based on those test results. The recommendations described in the document are for blood establishments that use either nontreponemal-based or treponemal-based screening assays to test donors for serological evidence of syphilis infection. These recommendations, when finalized, will replace previous recommendations contained in a Memorandum to Registered Blood Establishments dated December 12, 1991.