FDA REGULATIONS REGARDING EGG DONATION

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.

FDA issues regulations

FDA Regulatory Information PDF

ASRM FDA Page