FDA Information for Directed Donors

For Trent's FDA registration as a Directed Donor, see Organization Information.

The following is from California Health And Safety Code Section 1644.5:

• "A recipient of sperm, from a sperm donor known to the recipient, may waive a second or other repeat testing of that donor if the recipient is informed of the requirements for testing donors under this section and signs a written waiver."

The U.S. Food and Drug Administration (FDA) issued regulations in May of 2005, which require that sperm donors are screened and tested for communicable diseases by FDA-registered facilities and that the screening and testing be done in accordance with FDA-established procedures.

The following is taken from the FDA homepage at: http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm102842.htm

• "What special requirements apply to directed semen donors?"
  
  "Directed semen donors must be tested at the time of donation, but do not have to be retested 6 months later (as do anonymous semen donors) [1271.85(d)]. The term "directed reproductive donor" means a reproductive donor who knows and is known by the recipient before donation [1271.3(l)]. Reproductive cells or tissues from a directed semen donor who has been determined to be ineligible (e.g. donors who test positive or indicate a risk factor for a relevant communicable disease) are not prohibited from use. Special labeling of the HCT/P [human cell tissue product] is required to indicate increased risk of relevant communicable disease [1271.65(b)]."
  
• "A six-month quarantine for donations and retesting of directed semen donors is not required [1271.85(d)]. "

Trent is a Directed Donor and the recipient signs and notarizes understanding of this status in the required Directed Donor Agreement.  Trent's background and identity is freely available to all prospective recipients and their physicians. Trent has been tested against communicable disease and results have been posted online.  Recipients with fertility issues often seek unfrozen semen (unquarantined / uncryopreserved) for possible increased pregnancy odds over frozen semen. Directed donor sperm specimens from Trent are labeled with the following:

"NOT EVALUATED FOR INFECTIOUS SUBSTANCES'' and "WARNING: Advise recipient of communicable disease risks"

Trent's donor status as a Directed Donor is on file with the US FDA.
 

The FDA website describing approved Donor testing is:

• Testing HCT/P Donors: Specific Requirements:
  http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm151757.htm 
   
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays:
  ^{http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/BloodDonorScreening/InfectiousDisease/ucm080466.htm} 
   
• Code of Federal Regulations Title 21
  PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
  Subpart C--Donor Eligibility  Sec. 1271.85 What donor testing is required for different types of cells and tissues?https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=1271.85