In the June 22, 2016, Federal Register, FDA issued a final rule amending certain donor eligibility regulations to increase access to embryos donated for reproductive use. The rule expands the exceptions under 21 C.F.R. § 1271.90 and allows the use of embryos originally formed for reproductive use for a specific individual or couple and now intended for directed or anonymous donation for reproductive use, provided that specific criteria (e.g., labeling requirements) are met. The final rule is substantially similar to the proposed rule FDA issued in the December 31, 2014, Federal Register. The rule is effective August 22, 2016.
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