You could build a similar game, make no specific claims (or get a small focus-group to test it out), get a psychologist or two interested with a free trial, the

You could build a similar game, make no specific claims (or get a small focus-group to test it out), get a psychologist or two interested with a free trial, then transition to a respectable price later if it is adopted by the clinical community without FDA aproval. Or a modification of that ptocess, still without FDA approval. I don't think psychotherapy in general is FDA approved, as far as I can see, so I'm not even sure what the point of FDA approval is other than proving a principle of therapeutic effect to charge a high price and get access to the psychiatry market in addition to the psychology market.