ASRM Today discusses the latest breakthroughs in AI and reproductive medicine
Jul 10, 2023
In the USA, the Food and Drug Administration plans to regulate artificial intelligence and machine learning software systems as medical devices to improve the quality, consistency, and transparency of their performance across specific age, racial, and ethnic groups.
Embryology procedures do not fall under the federal regulation of “CLIA 88.” They are not tests per se; they are cell-based procedures. Likewise, many add-on procedures related to embryology, such as preimplantation genetic testing, are considered “laboratory-developed tests” and are not subject to Food and Drug Administration regulation, at present.
Should predictive artificial intelligence…