The FDA doesn’t plan to regulate access to raw genetic data; and context for Gutierrez scare-mongering about ovary removal : Genetic Future:

“…In other words, the FDA has stated on the record that if a company offers to sell you your genome sequence without interpretation, they can do so without FDA intervention. And if you then wish to take that genome sequence and run it through any of the growing list of open-access tools for interpretation (such as Promethease), you’re free to do so…”