Final Guidance: Mouse Embryo Assay for Assisted Reproduction Technology Devices

Read about the final guidance on Mouse Embryo Assay for Assisted Reproduction Technology Devices

If your email program has trouble displaying this email, view as a webpage. FDA Issues Final Guidance on Mouse Embryo Assay for Assisted Reproduction Technology Devices Today, the U.S. Food and Drug Administration (FDA) issued this final guidance: Mouse Embryo Assay for Assisted Reproduction Technology Devices - Guidance for Industry and Food and Drug Administration Staff. The final guidance provides recommendations for how to perform the mouse embryo assay (MEA), a commonly used test method to assess whether an assisted reproduction technology (ART) device, such as an in vitro fertilization medium or embryo transfer catheter, has the potential to cause a toxic effect on human embryos. Mouse embryo assay results can be used to support premarket submissions for ART devices and are also used to evaluate each lot of an ART device following manufacturing. Read the Guidance Facts about the final guidance This guidance provides recommendations for the mouse embryo assay. This final guidance includes recommendations on: How the MEA testing should be conducted to support premarket submissions for ART devices. Labeling that includes the acceptance criterion used for the test. Questions? If you have questions, contact the Division of Industry and Consumer Education.

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