Why You Should Work With an FDA-Approved Fertility Clinic Outside of the US

The FDA does not approve or license fertility clinics, in the United States or abroad. What it does is regulate human cells and tissues, including eggs, sperm, and embryos, under federal rules in 21 CFR Part 1271. Establishments that recover, screen, test, process, store, or distribute these tissues must register with the FDA, and establishments outside the United States must register if they import, or offer for import, reproductive tissue into the US. The FDA states that accepting a registration is not a determination that the establishment complies with every rule, and it is not an approval. So when a clinic abroad describes itself as “FDA-approved,” the accurate question to ask is whether it is FDA-registered and what that registration covers.

At Chedid Grieco, our Sao Paulo facility is registered with the FDA as a tissue establishment and also holds a New York State tissue bank license and a California provisional tissue bank license, which you can review on our licenses and associations page. We hold consultations in Miami and provide treatment in Brazil, as described on our fertility tourism page, and we would rather patients understand exactly what these credentials mean than rely on a label.

What FDA Registration Covers for a Fertility Clinic

FDA oversight of reproductive tissue focuses on preventing the transmission of communicable diseases. Under Part 1271, a registered establishment lists the types of tissue it handles and the functions it performs, and for donated eggs, sperm, and embryos it must follow donor eligibility rules, which include screening a donor’s medical and social history and testing for specified infectious diseases before the tissue can be used. These rules apply most directly to donor eggs, donor sperm, and donor embryos; tissue used between sexually intimate partners is handled under different, more limited requirements.

Registration also creates accountability. A registered establishment is on record with the FDA, can be inspected, and must keep the documentation that a US receiving clinic expects to see. That documentation matters most when eggs, sperm, or embryos created abroad will later be shipped to the United States, which we explain in our articles on shipping donor eggs from Brazil to a US clinic and transporting embryos from overseas back to the US.

What FDA Registration Does Not Mean

Because the word “FDA” carries so much weight, it is easy to read more into registration than it actually says. The FDA’s own tissue establishment registration guidance states that accepting a registration does not mean the establishment has been found to comply with all applicable rules, and does not mean any product is licensed or approved by the FDA.

Registration also does not evaluate a clinic’s pregnancy or live birth rates, the skill of its physicians, or how its embryology laboratory performs day to day. Those questions are answered by other credentials, by published outcome data where it exists, and by a frank conversation with the clinic. A registered clinic can be an excellent choice, but registration on its own is a baseline for tissue safety, not a ranking of quality.

How to Verify a Clinic’s FDA Registration Yourself

You do not need to take any clinic’s word for its registration status, including ours. The FDA publishes a free Human Cell and Tissue Establishment Registration public query that lets anyone search registered establishments by name, country, function, and status.

When you search for a clinic abroad, check the following details:

• Status: The record should show an active registration rather than an inactive or pre-registered firm.
• Legal name and location: The name and address should match the facility where your treatment will actually take place.
• Functions: Look for the steps relevant to you, such as recovery, screening, testing, processing, storage, or distribution.
• Tissue types: Confirm that the listing includes the reproductive tissue you plan to use, such as oocytes, embryos, or semen.

It is also reasonable to ask the clinic directly for its FDA establishment identifier and for copies of any state licenses it cites, then compare those documents with the public record. A clinic that is comfortable with that request is usually a clinic that keeps its documentation in order.

Other Credentials Worth Checking at a Clinic Abroad

FDA registration is one layer. Some US states license tissue banks separately, and New York and California are two states whose tissue bank licenses are commonly cited by clinics that serve US patients, a topic we cover in more depth in our article on how FDA and NYDH licensing support fertility care standards and our overview of California licensing for international fertility clinics. In the clinic’s home country, look for authorization from the national health regulator, which in Brazil is ANVISA, and for compliance with national medical rules, which in Brazil come from the Federal Council of Medicine.

Professional memberships add context as well. Our licenses and associations page lists our memberships in the American Society for Reproductive Medicine, the European Society of Human Reproduction and Embryology, and the Brazilian societies of human and assisted reproduction, along with our Red Latinoamericana de Reproduccion Asistida certificate. Memberships are not licenses, but they show which professional standards and data-reporting networks a clinic has chosen to participate in.

Questions to Ask Before Choosing a Clinic Outside the US

Credentials are a starting point for a conversation, not the end of one. Before committing to a clinic abroad, ask how the clinic reports its outcomes and for which age groups, who will perform your retrieval and transfer, how monitoring will be handled before you travel, what happens to any frozen eggs or embryos if your plans change, and how records will be shared with your doctors at home. Our guide to choosing an international fertility clinic walks through these questions in more detail.

It is also worth asking how a clinic’s credentials apply to your specific plan. If you expect to ship donor eggs or embryos to the United States, FDA registration and donor eligibility documentation become essential. If all of your treatment will happen abroad and nothing will be imported, those credentials still signal careful tissue handling, but other factors, such as the laboratory, the medical team, and the clinic’s communication with you, may weigh more heavily in your decision.

Weighing the Benefits and Trade-offs of Treatment Abroad

Many patients look abroad because of cost. For people paying out of pocket, a cycle in Brazil, travel included, can come in below a comparable cycle in the United States, which our comparison of IVF costs inside and outside the United States explores. Some patients also value shorter wait times or access to approaches such as in vitro maturation that are offered at fewer clinics.

There are trade-offs to plan for, including time away from work, travel during a medically sensitive window, and coordination between doctors in two countries. None of these rule out treatment abroad, but they deserve the same careful attention as credentials. Outcomes always depend on individual factors such as age and diagnosis, and no clinic, in any country, can guarantee a pregnancy.

Work With Chedid Grieco for Fertility Care in Sao Paulo

Chedid Grieco is a female-led clinic, and Dr. Silvana Chedid introduced intracytoplasmic sperm injection to Brazil in 1992. Our Sao Paulo facility is FDA-registered as a tissue establishment and holds a New York State tissue bank license, a California provisional tissue bank license, and an ANVISA license, and our team has helped bring nearly 9,000 babies into the world. We welcome patients of all backgrounds, including LGBTQI+ individuals and couples, and we are glad to show you our registration and licenses before you make any decision.

For Miami patients, consultations take place close to home, and our team coordinates the clinical and travel steps of treatment in Brazil. If you would like to talk through whether working with a clinic outside the United States makes sense for you, reach out through our contact form to schedule a consultation.

Frequently Asked Questions About FDA-Registered Fertility Clinics Abroad