FDA Finalizes Embryo Donation Rule for In Vitro Fertilization

A final FDA rule makes it easier to donate frozen embryos to another individual or couple, according to a June 22 Federal Register notice (81 Fed. Reg. 40,512).

The final rule, Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products, (HCT/Ps) establishes a new exception in the Food and Drug Administration regulations (21 C.F.R. 1271) that cover donor eligibility of embryos.

Under the new rule, embryos formed by individuals who haven’t been screened for communicable diseases for their own reproductive use could be made available to others for that purpose. The rule ...