23andMe Personal Genome Service regulatory update

23andMe said it submitted 510(k) documentation to FDA for 7 undisclosed tests, which are among those offered by its Personal Genome Service. The tests will be reviewed under a de novo pathway, an alternative path to market for devices that are lower risk and may not require a PMA, but are of a new type and would not be cleared in a 510(k) premarket notification. 23andMe uses a CLIA-certified laboratory to process customer DNA samples for its Personal Genome Service, which provides more than 200 health and trait reports as well as genetic ancestry information. ...