Why did the FDA shut down 23andME
Because of its intended uses, 23andme’s PGS was considered a medical device, but 23andme failed to comply with FDA’s regulations for devices. In order to legally market its PGS, 23andme would have had to obtain premarket approval or de novo classification. According to this FDA warning letter (), FDA had confronted 23andme about its failure to comply on multiple occasions. FDA was concerned that 23andme’s unapproved product may give consumers false results regarding their health risk for certain conditions and diseases, which could be dangerous.
Though its PGS is no longer being marketed in the USA, 23andme is still selling its ancestry-background tests.