Direct-to-consumer genetic tests are becoming more prevalent. Pathway Genetics strikes a distribution deal with Walgreens, but draws FDA scrutiny over whether needed regulatory filings have been performed.
Many telehealth, ehealth, mhealth, etc. product companies have assumed that their products and services will move easily through the FDA or that they don’t even need to interact with the agency. Recent statements by agency personnel, and handling of certain filings, should be warning that dealing with FDA regulations is not that simple.