Starting a surrogacy journey is an exciting time, filled with hope and anticipation. But let’s be honest—navigating medical regulations can feel overwhelming. One of the most critical and often confusing requirements is the FDA donor eligibility testing for surrogacy.
Don’t worry—this guide breaks it down in plain English: what “FDA testing” means, who needs it, and how to prepare for a smooth, on-time process. Whether you are based in the U.S. or created your embryos overseas—in the UK, Hong Kong, Japan, Singapore, or elsewhere—you’ll learn exactly what’s required before transferring embryos to a gestational carrier.
What Is FDA Donor Eligibility, and Who Needs It?
When you use your sperm and/or eggs to create embryos that will be transferred to a gestational carrier in the United States, the Food and Drug Administration (FDA) has specific rules to ensure safety.
The core requirement is a Donor Eligibility Determination (DED) under 21 CFR Part 1271. Here’s the most important thing to know:
- The testing applies to the gamete providers—the person providing the sperm and the person providing the eggs.
- Your gestational carrier (GC) is considered the recipient, not a donor. She does not undergo FDA donor eligibility testing. Your clinic will still perform comprehensive health screening for her, but that is a separate clinical process.
Under federal regulation¹, your fertility clinic must determine that the donors are eligible before any embryo transfer can happen. This determination is based on three components:
- Medical & Social History – a detailed questionnaire covering risk behaviors, travel/exposure history, and past transfusions or transplants.
- Physical Exam – a general physical (including a genital exam for reproductive donations) to look for signs of communicable disease.
- Infectious-Disease Testing – a specific panel of lab tests using FDA-licensed/approved/cleared donor-screening assays performed in a qualified CLIA-certified laboratory (or equivalent).
The Required Infectious-Disease Tests
All gamete donors must be tested for the following Relevant Communicable Disease Agents or Diseases (RCDADs):
- HIV-1 and HIV-2
- Hepatitis B virus (HBV)
- Hepatitis C virus (HCV)
- Syphilis
For reproductive cells/tissues (sperm and eggs), the FDA also requires testing for:
- Chlamydia trachomatis
- Neisseria gonorrhoeae
Because semen is considered a viable, leukocyte-rich tissue, sperm providers must also be tested for:
- Human T-lymphotropic virus (HTLV-I/II)
- Cytomegalovirus (CMV)²
Note: CMV isn’t classified as an RCDAD, but CMV testing is still required for semen donors, and your clinic must have a written SOP describing how CMV-reactive results are managed.
Timing Is Everything: How “Fresh” Must Tests Be?
The FDA sets strict timing windows so that test results accurately reflect the donor’s health status at the time of donation:
- General rule: collect donor specimens at recovery or within 7 days before/after the date of gamete retrieval/collection.¹
- Oocyte donors: testing may be done up to 30 days before retrieval (helpful because stimulation often lasts longer than a week).
- Directed semen donors (most intended fathers): test within 7 days before/after each collection. Following this 7-day rule means you can avoid the six-month quarantine that applies to anonymous semen donors.¹
What If Our Embryos Were Created Years Ago or Overseas?
This is common for international intended parents or families on a long fertility journey. Here’s what to know:
If embryos were created in another country—such as the UK, Hong Kong, Japan, or Singapore—and you plan to use them for surrogacy in the U.S., the original sperm and egg providers must still meet U.S. FDA standards. Your U.S. clinic will audit the original paperwork.
If the original testing doesn’t comply (wrong assays, timing outside the window, or missing records), clinics typically present two options:
- Re-screen & Re-test. The original gamete providers complete new questionnaires and undergo new blood tests to become eligible.
- Limited Use With Special Labeling. In narrow situations, embryos may be used with special labels acknowledging non-standard testing. Many U.S. programs adopt stricter internal policies and may decline this pathway for safety and liability reasons.
Pro Tip: If your prior tests were done overseas, plan ahead. Your U.S. clinic may ask you to re-draw and test through a U.S. CLIA lab or ship specimens to a lab that uses FDA-licensed/approved/cleared donor-screening assays.³
Your Essential Paperwork Checklist
Provide a complete, clean file for each gamete provider to keep your timeline on track:
- ✅ Donor History Questionnaire and physical-exam documentation.
- ✅ Lab reports listing the assay name/manufacturer, collection dates, and results for all required panels.
- ✅ The signed Donor Eligibility Determination / Summary of Records stating the donor has been determined “eligible.”
Common Pitfalls to Avoid
- Timing misses. The most frequent error is testing too early/late. Work backward from retrieval/collection dates.
- Panel gaps. Don’t forget Chlamydia/Gonorrhea for reproductive donors and HTLV/CMV for semen donors.
- Non-compliant testing. Using a lab without CLIA certification or assays not licensed/approved/cleared by the FDA for donor screening. Verify this with your clinic.
- Testing the wrong person. Your GC is the recipient, not the donor; she doesn’t undergo FDA DED testing.
Frequently Asked Questions (FAQs)
1) Does our gestational carrier need FDA donor testing?
No. She is the recipient, not a donor. She will still have thorough clinical screening per your program’s protocol, but it’s separate from the FDA DED rules.
2) Which tests are absolutely required?
For all donors: HIV-1/2, HBV, HCV, syphilis. For reproductive donors: Chlamydia and Gonorrhea. For semen donors: add HTLV-I/II and CMV (with an SOP for CMV-reactive cases).
3) How recent do the tests need to be?
Within 7 days of recovery/collection (general rule). Oocyte donors may test up to 30 days before retrieval. Directed semen donors must be within 7 days of each collection.
4) We made embryos overseas years ago. Can we use them in the U.S.?
Often yes—provided your clinic can audit records and confirm compliance. If there are gaps, expect re-testing discussions (and, rarely, labeling pathways that many clinics don’t use).
5) Do the tests have to be done in the U.S.?
Not necessarily. The key is using FDA-licensed/approved/cleared donor-screening assays at a qualified (CLIA) lab. Many international families draw blood locally and courier specimens to a compliant U.S. lab.
6) Why do some clinics ask for more than the FDA requires?
The FDA sets the floor for safety. Clinics may set a higher ceiling with internal policies for quality and logistics. Always follow your clinic’s protocol.
Key Takeaways
- In U.S. surrogacy, gamete providers must pass the FDA’s Donor Eligibility Determination; the GC is a recipient and not subject to DED testing.
- Hit the 7-day/30-day timing windows and use FDA-licensed/approved/cleared assays at a CLIA lab.
- If embryos were created abroad—in the UK, Hong Kong, Japan, Singapore, or elsewhere—start record review early to identify and fix compliance gaps.
- Keep a complete Summary of Records to speed clinic clearance.
Ready to Use Embryos Created Overseas? We Can Help.
Whether your embryos were created in the UK, Hong Kong, Japan, Singapore, or another country, Ivy Surrogacy can guide you through FDA compliance requirements and help you connect with the right U.S. IVF clinic.
How we support you:
- Reviewing your case background so you understand which donor eligibility requirements may apply
- Helping you prepare the documents your U.S. clinic will need for review
- Assisting international intended parents in connecting with experienced U.S. IVF clinics
- Providing general guidance on typical timelines, paperwork, and questions to ask your clinic
Next step: Contact our team, share where your embryos were created and which U.S. clinic you plan to work with, and we’ll help you begin the process with confidence.
Regulatory References
¹ U.S. Food and Drug Administration. (2024). Title 21, Code of Federal Regulations, Part 1271: Human Cells, Tissues, and Cellular and Tissue-Based Products. eCFR Link
² U.S. Food and Drug Administration. (2024, May 2). Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). FDA.gov
³ Human Fertilisation & Embryology Authority (HFEA). Importing and exporting sperm, eggs and embryos. HFEA.gov.uk
