Read and Submit Your Input on the FDA's Draft Guidance on the Mouse Embryo Assay for Assisted Reproduction Technology

Today, the U.S. Food and Drug Administration (FDA) issued for comment a new draft guidance that includes proposed recommendations on how to perform the mouse embryo assay, a commonly used test to assess whether an assisted reproduction technology device, such as in vitro fertilization, has a toxic effect on human embryos. Mouse embryo assay results can be used to support premarket submissions for assisted reproduction technology devices and are also used to evaluate each lot of an assisted reproduction technology device before releasing it onto the market.

The recommendation in the draft guidance address the types of assisted reproduction technology devices that should be tested using the mouse embryo assay and how this testing should be completed. The FDA also proposes that assisted reproduction technology devices tested with the mouse embryo assay should provide labeling that includes the acceptance criterion, such as numerical limits, ranges or other criteria used for the test. This draft guidance, when finalized, will also help manufacturers comply with the FDA’s existing requirements for assisted reproduction technology devices to be tested with the mouse embryo assay. Submit comments on the draft guidance by August 12, 2019.

Read the Draft Guidance