by: ASRM Office of Public Affairs
Orginally published in ASRM Bulletin Volume 18, Number 25
In a new final rule published in Wednesday’s Federal Register, FDA has amended regulations on donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular ant tissue-based products (HCT/Ps). (21 CFR Part 1271)
The new rule affects the subsequent directed or anonymous donation of embryos originally created for the reproductive use of a specific individual or couple and takes effect August 22, 2016.
Under the current rule, adopted in 2007, embryos created for intimate partners are exempted from the donor eligibility requirements, so when such a couple wishes to donate their unneeded embryos to other patients after they’ve completed their family, there may or may not be test results to go along with the embryos.
In the new rule, FDA clarifies that embryos created for patients’ own reproductive use and then donated are excepted from donor eligibility requirements and may be donated to other patients. However, FDA also makes it clear that they are not creating an exception for deficiencies in donor eligibility determination or deficiencies in performing donor testing or screening. So- if donor eggs or sperm were used in the creation of the embryos to be donated, any required donor screening and testing must have been done and be on record. And, to the extent possible, there should be screening and testing of members of the sexually intimate couple whose gametes were used to create the embryos, prior to transferring the embryos to the recipient patient. The exception allows for the donation of the embryos of the sexually intimate couple without this screening and testing- if it cannot be done.
Revised labeling requirements are included in the new rule. In order to ensure that physicians are able to give their patients specific and accurate information, and that patients can make informed medical decisions, the rule requires appropriate labeling for donor embryos describing the eligibility status of the individual donors whose gametes were used to form the embryo. The labeling must note if screening and testing were not performed at the time of recovery or cryopreservation of the reproductive cells or tissue, but were performed subsequently.
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