FDA-ELIGIBILITY OF THE EGG DONOR AND LICENSES OF A.EggBank
WHAT DOES FDA-ELIGIBILITY OF THE EGG DONOR MEAN?
FDA REQUIREMENTS FOR EGG DONORS
These Egg Donor requirements are necessary to ensure a positive experience and the birth of a healthy baby.
They are also part of the guidelines established by the Food and Drug Administration (FDA). The FDA oversees all Donor tissue programs, including Donor Eggs, and requires us to ask specific questions about Donor`s health history, sexual history, and other health-related activities as part of the Egg Donor qualification process.
Using third-party reproductive tissue is similar to giving or receiving an organ transplant, as it carries a risk of transmitting infectious diseases. This is why the FDA has several special requirements (FDA regulations for Egg Donors) to prevent the spread of infections during the treatment process.
For oocytes (eggs) donated by the Egg Donor to be transported and used in infertility treatment at any clinic in the USA, the Egg Donor is mandated to undergo a comprehensive medical examination at an FDA and CLIA-certified Laboratory. Without meeting this requirement, the Donor1s Eggs unfortunately cannot be used in a US clinic.
At A.EggBank, our Egg Donors are tested at the FDA and CLIA-certified laboratories in the US such as Unilab, Innovative Health Diagnostics, Viromed, in addition to the tests conducted at our Ukrainian ISO-certified Labs. This ensures that our Egg Donors meet the FDA eligibility criteria for Donors, providing you with confidence in the quality and safety of the donated Eggs for your infertility treatment.
Additionally, Egg Donor must complete a Risk Factor Questionnaire and be approved based on the results of the Risk Factor Questionnaire Review as a Donor eligible for donation. For instance, Donors who have spent 5 years or more cumulatively in Europe from 1980 to the present (including time spent in the U.K. from 1980 through 1996) will likely not be recognized as eligible Donors in the US.
We provide frozen oocytes from FDA-eligible donors only, which gone through FDA testing for Egg Donors. Our Donors have never lived in the countries listed in the risk factors.
VERIFYING FDA-ELIGIBILITY: HOW TO DETERMINE IF YOUR SELECTED EGG DONOR ON A.EggBank WEBSITE IS FDA-ELIGIBLE?
FDA eligibility determination for Donors
Each donor profile on our website is accompanied by an FDA icon(
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) , indicating that the Egg Donor has successfully completed all required medical tests at an FDA certified laboratory and meets FDA regulations on Egg donors.
The presence of the icon
( ) indicates that the Donor currently does not have valid FDA tests (or FDA screening for Egg Donors), so she does not meet FDA regulations for Egg Donors.
However, if you are interested in purchasing oocytes from such a donor, please leave us your request, and we will provide you with detailed information regarding the conditions and terms for testing this Donor at an FDA certified laboratory.
This process will enable us to make the Donor FDA-eligible, ensuring compliance with the necessary regulations and standards. Importantly, this will NOT incur any additional costs.
WHY IS FDA-ELIGIBILITY OF THE EGG DONOR IMPORTANT?
Usage of Donor Eggs in US Clinics: If you intend to use the Donor`s eggs at a clinic in the USA, it is essential for Egg donors to undergo FDA screening and successfully pass Risk Factors Questionnaire. This eligibility ensures that the eggs can be shipped and utilized within the territory of the USA without any legal restrictions.
Creation of Embryos at ADONIS Medical Group in Ukraine: If you plan to create embryos and use them at ADONIS Medical Group of Companies in Ukraine, having an FDA-eligible egg donor becomes crucial if you want to have the option of transferring the remaining embryos from Ukraine to the USA at a later stage. Without FDA screening for the Egg donors, such a shipment would not be possible.
Preference for FDA-Certified Testing: In cases where you do not intend to use the Donor`s eggs in a US clinic, but still prefer that the Egg donor undergoes medical tests at an FDA certified laboratory, it ensures a higher level of confidence in the donor`s health and suitability for the intended use. It is possible thanks to the FDA requirements for Egg donors.
CAN I USE DONOR’S EGGS IN CALIFORNIA STATE?
FDA testing and the successful completion of the Risk Factors Questionnaire for the Egg Donors are of significant importance for various reasons, including:
Usage of Donor Eggs in US Clinics: If you intend to use the Donor`s eggs at a clinic in the USA, it is essential for Egg donors to undergo FDA screening and successfully pass Risk Factors Questionnaire. This eligibility ensures that the eggs can be shipped and utilized within the territory of the USA without any legal restrictions.