FDA Releases Guidance To Test Reproduction Devices For Toxicity

FDA on Thursday (June 13) released draft guidance meant to help industry conduct tests on assisted reproduction technology (ART) devices, in order to ensure companies screen for toxicity. Most companies use mouse embryo assays (MEA) to support premarket device submissions, but until now there have been no consensus standards for how to conduct an MEA, FDA explains in the guidance. Most ART devices come into direct or indirect contact with gametes and/or embryos during their intended use, so it is...