The Food and Drug Administration (FDA) has announced the release of a final guidance document titled "Mouse Embryo Assay for Assisted Reproduction Technology Devices." This guidance provides recommendations on conducting the mouse embryo assay (MEA), which is used to evaluate the potential for embryotoxicity of devices that come into contact with gametes and/or embryos. The FDA has revised the guidance based on public comments and has made several technical clarifications. The document emphasizes that following FDA guidelines is not mandatory and alternative approaches are acceptable if they meet relevant requirements.
Simple Explanation
The FDA has shared some advice on how to test if certain tools used in helping make babies are safe by using a mouse embryo test. If people want to do things differently than the guidance suggests, that's okay too, as long as the tools are safe.