ASRM: FDA Announcement

FDA Issues Regulations on Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling- Testing Requirements are Modified for Egg Donors and Embryo Donors

The FDA has issued regulations modifying the donor eligibility final rule and the current good tissue practices final rule. All of these rules will take effect May 25, 2005.

The new regulations remedy the concerns we had about the timing requirements for infectious disease testing for egg donors and the testing requirements for couples who complete their families and then decide to donate their remaining embryos to another infertile couple.

For Egg Donors:
The new regulations permit the collection of a specimen for testing an egg donor for infectious diseases up to 30 days before her retrieval. This change allows testing to be completed prior to the donor beginning her ovarian stimulation and relieves the donor, recipient, and doctor of the worry that the testing (originally required to be within seven days prior to the retrieval) might have to be repeated several times if the retrieval were delayed or that results might not be available if the timing of the retrieval were to be moved up.

For Embryo Donors:
The new regulations add an exemption from screening and testing for cryopreserved embryos that, while originally exempted from the donor eligibility requirement (because donors were sexually intimate partners) are later intended for anonymous or directed donation. This change allows couples who complete their families to donate their remaining frozen embryos to other infertile couples even though they did not undergo screening tests at the time their sperm and eggs were recovered. The new rule requires that appropriate measures be taken, when possible, to screen the donor couple before transfer of donated embryos to the recipient. When screening and testing take place after the embryos are frozen and before transfer to a recipient, labeling requirements apply and the recipient must be advised that screening and testing of the donor(s) were not performed at the time of cryopreservation of the reproductive cells or tissue, but were performed subsequently. If screening and testing of the donor couple are not performed, the labeling requirements call for the embryos to be labeled, “NOT EVALUATED FOR INFECTIOUS SUBSTANCES” and “WARNING: Advise recipient of communicable disease risks.” The treating physician would then discuss the potential risks with the recipient of the donated embryos.

The rule (Interim Final Rule on Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling) may be read on FDA’s website: http://www.fda.gov/cber/rules/hctdnr.pdf
Also see Questions and Answers: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Interim Final Rule http://www.fda.gov/cber/rules/hctdnrq&a.htm

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