FDA Amends Regulations Concerning Embryo Donation

Responding to “enhanced understanding in this area” and “comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos,” the U.S. Food and Drug Administration recently issued a final rule amending regulations “regarding donor eligibility of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling.”  [See 81 Fed. Reg. 40512, 6/22/16 and 21 C.F.R. § 1270.90 Are there exceptions from the requirement of determining donor eligibility, and what labeling requirements apply?]  The rule provides “additional flexibility to HCT/P establishments to make available for reproductive use embryos originally intended for reproductive use for a specific individual or couple when those embryos are subsequently intended for directed or anonymous donation.”  It does not create an exception for deficiencies that occurred in making the donor eligibility determination or for deficiencies in performing donor screening or testing.  Consistent with current regulations, the rule “requires appropriate labeling for embryos that would describe the donor eligibility status of the individual donors whose gametes were used to form the embryo.”