“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers.”
The FDA stated genetic testing kits like those offered by 23andMe will be classified as Class II diagnostics and thus don’t have to receive a government OK before marketing their products. The FDA now opens this ruling to public comment for the next 30 days.