FDA today issued an update regarding 23andme’s Bloom Syndrome carrier testing de novo approval as a class II medical device (DEN140044). A copy of FDA’s letter to 23andme is attached. Please also find below a link to FDA’s Decision Summary for this product and it’s limited, narrow use.
FDA’s approval of the de novo classification request and Decision Summary are specific to 23andme’s Bloom Syndrome test, and the Agency has not yet issued a general guidance describing how it intends to allow other carrier tests to be available as class II (but 510(k) exempt) medical devices. We expect that the guidance will set out similar limitations in labeling and use as the Bloom Syndrome carrier test, and require similar performance characteristics for any subsequent autosomal recessive trait to qualify as an exempt, class II device. This decision also does not appear to preclude carrier testing from being offered as LDT services by high complexity CLIA laboratories as they are currently available under FDA enforcement discretion. Additionally, under FDA’s proposed LDT framework, the existence of a similar, FDA-regulated carrier in vitro diagnostic devices would place other carrier LDTs on a shorter timeline to FDA regulation than novel (low risk) LDTs.