1997N-0484T Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling
FDA Comment Number : EC1
Submitter : Miss. DAWN Hunt Date & Time: 08/03/2005 02:08:02
Organization : Fertility Alternatives, Inc
Category : Other Organization
Issue Areas/Comments
GENERAL
GENERAL
There is no indication in your documents with regards to curable infectious diseases for tissue donors, such as Chlamydia (for oocyte donors). If a donor tests positive for a bacterial infection that can be cured by antibiotics, it should state that donors can qualify after treatment and they retest negative.