Thursday, 6 November 2014

FDA new blood - syphilis guidance


The FDA has issued a new document:

“Guidance for Industry: Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis”

The guidance is intended for blood establishments that collect Whole Blood or blood components, including Source Plasma. The guidance announced in this notice finalizes the draft guidance of the same title, dated March 2013 (2013 draft guidance), and supersedes the memorandum of December 12, 1991, entitled “Clarification of FDA Recommendations for Donor Deferral and Product Distribution Based on the Results of Syphilis Testing.”

For details see: FDA

Posted by Tim Sandle