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FDA donor eligibility testing: what fertility clinics and egg and sperm banks need to know

Oct 22
6 min read
Illustration of a donor eligibility test kit with blood tubes, a checklist and a sample shipping container

Every donated egg and sperm sample in the US carries a federal paper trail. Before reproductive cells from an anonymous or directed donor can be used, the establishment responsible must determine that the donor is eligible, and infectious disease testing is a central part of that decision.


For fertility clinics, egg donor agencies and sperm banks, the rules are well established but easy to trip over. A specimen drawn a few days outside the window, a test that isn't labeled for donor screening or a missing chlamydia and gonorrhea result can all hold up a cycle.


This guide summarizes what federal regulations and FDA guidance require for reproductive tissue donors. It's educational only and isn't legal or medical advice. Each establishment is responsible for its own donor eligibility determinations and should rely on the regulations and its regulatory advisors.



Who regulates donated eggs and sperm


The FDA regulates donated reproductive tissue, including oocytes and semen, as human cells, tissues and cellular and tissue-based products (HCT/Ps). According to FDA's page What You Should Know: Reproductive Tissue Donation, any establishment that performs a manufacturing step must register with FDA and list its HCT/Ps under 21 CFR Part 1271. Manufacturing steps include recovery, processing, storage, labeling, packaging and distribution. FDA can inspect these establishments.


Donor eligibility rests on two parts:


  • Screening: a review of the donor's relevant medical records, a current medical history interview covering medical history and relevant social behavior, and a current physical examination.

  • Testing: laboratory testing of a donor specimen for relevant communicable disease agents and diseases.



Which tests are required


The testing requirements are set out in 21 CFR 1271.85. They build on each other by donor type.



All donors


Every donor must be tested for:


  • Human immunodeficiency virus, types 1 and 2 (HIV-1 and HIV-2)

  • Hepatitis B virus (HBV)

  • Hepatitis C virus (HCV)

  • Treponema pallidum (syphilis)


FDA's page on specific testing requirements for HCT/P donors explains what this means in practice:


  • HIV: an anti-HIV-1 test (or a combined HIV-1/2 test) plus an HIV-1 nucleic acid test (NAT), and an anti-HIV-2 test or combination test. If the HIV antibody test can't detect HIV-1 group O, the donor must be screened for group O risk factors.

  • Hepatitis B: hepatitis B surface antigen (HBsAg), total antibody to the hepatitis B core antigen (IgG and IgM) and HBV NAT.

  • Hepatitis C: an HCV antibody test plus HCV NAT.

  • Syphilis: an FDA-cleared screening test.



Living donors


FDA's current guidance on West Nile virus testing (final, September 2016) recommends that establishments test living HCT/P donors for West Nile virus using an FDA-licensed NAT. Egg and sperm donors are living donors, so WNV NAT is part of a standard donor panel. ASRM's donation guidance notes that WNV testing can be done year-round or seasonally, for gametes recovered between June 1 and October 31.



Sperm donors


Viable, leukocyte-rich cells or tissue also require testing for human T-lymphotropic virus types I and II (HTLV-I/II) and cytomegalovirus (CMV). FDA's reproductive tissue page states that sperm donors must be tested for HTLV and CMV in addition to the tests above.


The regulation also requires an establishment to have a standard operating procedure for releasing tissue from a donor whose specimen tests reactive for CMV.



All reproductive tissue donors


Donors of reproductive cells or tissue must also be tested for Chlamydia trachomatis and Neisseria gonorrhoeae. The regulation makes one exception: this testing isn't required if the cells are recovered by a method that ensures freedom from contamination by genitourinary tract organisms.



When specimens must be collected


Timing is where many delays start. Under 21 CFR 1271.80:


  • A donor specimen must generally be collected at the time of recovery, or up to 7 days before or after recovery.

  • For oocyte donors, the specimen may be collected up to 30 days before recovery.

  • Anonymous semen donors (ASRM now calls them nondirected donors) must provide a new specimen for retesting at least 6 months after the date of donation (21 CFR 1271.85(d)). FDA doesn't require this for directed donors, but ASRM recommends a 35-day quarantine and retest for directed sperm donors.


For egg donation, the 30-day window lets programs complete testing before stimulation is far along. Missing it usually means redrawing the donor and waiting for new results.



Which tests and labs qualify


The regulation also sets standards for how testing is done.


  • Tests must be appropriate FDA-licensed, approved or cleared donor screening tests, used according to the manufacturer's instructions.

  • For chlamydia and gonorrhea, where dedicated donor screening tests aren't available, tests must be FDA-licensed, approved or cleared and labeled for detecting these organisms in an asymptomatic, low-prevalence population.

  • Testing must be performed by a CLIA-certified laboratory, or one that has met equivalent requirements as determined by CMS.


A diagnostic test that's appropriate for a patient visit isn't automatically acceptable for donor eligibility. Confirm with your lab that each assay on the panel meets these requirements.



What makes a donor ineligible


A donor whose specimen is reactive on a required screening test must be determined ineligible. The regulation makes one exception for syphilis: a donor who is reactive on a non-treponemal screening test but negative on a specific treponemal confirmatory test isn't ineligible on that basis.



Exceptions for partners and autologous use


Under 21 CFR 1271.90, a donor eligibility determination isn't required for:


  • Cells and tissues for autologous use, such as a patient's own frozen eggs.

  • Reproductive cells or tissue donated by a sexually intimate partner of the recipient.


The rule includes specific labeling requirements for these situations. It also covers when cryopreserved material or embryos are later directed or donated to someone else.



Proposed FDA updates to watch


In January 2025, FDA issued draft guidance on determining eligibility of HCT/P donors. Draft guidance is published for comment and isn't for implementation. Until FDA finalizes it, the 2007 eligibility guidance and the requirements in 21 CFR Part 1271 remain the current standard. Donor programs should watch for the final version and update their SOPs when it's issued.



Testing recipients


Federal rules focus on donors, but professional guidance also addresses recipients. ASRM's current guidance on gamete and embryo donation (2024) notes there are no federal requirements for testing recipients. It nonetheless recommends tests to optimize perinatal care:


  • Blood type, Rh factor and antibody screen.

  • Documented immunity to rubella and varicella.

  • Infectious disease testing, including CMV IgG antibody for recipients using donor sperm.



Common mistakes and how to avoid them


  • Specimens drawn outside the window. Build the 7-day or 30-day window into scheduling, and send kits early enough for remote donors.

  • The wrong test on the requisition. Use a donor eligibility panel rather than assembling individual diagnostic tests.

  • Missing CT/NG. Unless the recovery method qualifies for the exception, chlamydia and gonorrhea testing is required for reproductive donors.

  • Forgetting HTLV and CMV for sperm donors. These are required for leukocyte-rich tissue, and a CMV-reactive result needs a written release procedure.

  • No 6-month retest for nondirected (anonymous) semen donors. Track retest dates from the donation date, not the first test.

  • Gaps in documentation. Keep lab reports and the test names used, and confirm each test meets FDA requirements, so the file supports the eligibility determination at inspection.



How IHDLab supports donor programs


IHDLab runs FDA donor eligibility panels for egg and sperm donors in-house at our CLIA-certified, FDA-registered lab (CLIA 05D2040304). We offer domestic, international and bulk donor kits, help coordinate remote blood draws and provide a downloadable FDA donor binder. See the full female and male donor panels on our FDA donor testing page.


For fertility clinics that need donor testing alongside IVF monitoring, our fertility and IVF testing page shows how the services fit together, including same-day hormone testing for stimulation cycles. Donor agencies and digital fertility platforms can read how we work with digital health partners.



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