This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they're reached out to them several times, and they've offered assistance through a group they specifically set up to help companies in this situation.<p>Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA's concerns.<p>Relevant quotes:<p>> Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.<p>> However, to date, your company has failed to address the issues described during previous interactions with the Agency or provide the additional information identified in our September 13, 2012 letter for (b)(4) and in our November 20, 2012 letter<p>> To date, 23andMe has failed to provide adequate information to support a determination that the PGS is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it; ...<p>> ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.<p>> As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies...<p>> Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS.