<story><title>FDA Warning Letter to 23andMe</title><url>http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm</url></story><parent_chain><item><author>jfasi</author><text>This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they&amp;#x27;re reached out to them several times, and they&amp;#x27;ve offered assistance through a group they specifically set up to help companies in this situation.&lt;p&gt;Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA&amp;#x27;s concerns.&lt;p&gt;Relevant quotes:&lt;p&gt;&amp;gt; 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.&lt;p&gt;&amp;gt; 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&lt;p&gt;&amp;gt; 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; ...&lt;p&gt;&amp;gt; ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.&lt;p&gt;&amp;gt; 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...&lt;p&gt;&amp;gt; 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.</text></item></parent_chain><comment><author>jxf</author><text>If you look at the FDA&amp;#x27;s website, it&amp;#x27;s littered with dozens of communications begging 23andme to submit some documentation about their product so that the FDA can evaluate the medical claims they&amp;#x27;re making.&lt;p&gt;See, e.g., this one from June 10, 2010:&lt;p&gt;[0] &lt;a href=&quot;http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM215240.pdf&quot; rel=&quot;nofollow&quot;&gt;http:&amp;#x2F;&amp;#x2F;www.fda.gov&amp;#x2F;downloads&amp;#x2F;MedicalDevices&amp;#x2F;ResourcesforYou&amp;#x2F;...&lt;/a&gt;&lt;p&gt;All the FDA wants in this letter is some kind of understanding that their genetic tests are actually valid and correct, since they are making medical claims regarding their accuracy:&lt;p&gt;&amp;gt; 23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Service™ is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Service™, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.&lt;p&gt;The FDA then establishes its ability to regulate this (remember, it&amp;#x27;s legally &lt;i&gt;required&lt;/i&gt; to do this):&lt;p&gt;&amp;gt; During a meeting between 23andMe and FDA on July 29, 2009, you described the 23andMe Personal Genome Service™ as consisting of a software program that analyzes genetic test results that are generated by an external laboratory in order to generate a patient specific test report. Thus, the 23andMe Personal Genome Service™ is a diagnostic device and subject to all applicable requirements of the Act.&lt;p&gt;They then very helpfully point them to all the forms, documents, etc., necessary to satisfy the legal requirements:&lt;p&gt;&amp;gt; For a device requiring premarket approval, the notification required by section 510(k)of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b).&lt;p&gt;There&amp;#x27;s even a helpful mailing address and fax number:&lt;p&gt;&amp;gt; Please direct your questions and response to: James L. Woods, Food and Drug Administration, 10903 New Hampshire Avenue, W066-5688, Silver Spring, MD 20993&lt;p&gt;Honestly, this sounds like 23andme has been getting away with something for a while and the FDA is tired of giving them leeway.</text></comment>
<story><title>FDA Warning Letter to 23andMe</title><url>http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm</url></story><parent_chain><item><author>jfasi</author><text>This seems absolutely reasonable. The letter indicates that the FDA has notified 23andMe that their products are not satisfactorily cleared, they&amp;#x27;re reached out to them several times, and they&amp;#x27;ve offered assistance through a group they specifically set up to help companies in this situation.&lt;p&gt;Meanwhile, 23andMe went ahead and began marketing and selling their product, despite the FDA&amp;#x27;s concerns.&lt;p&gt;Relevant quotes:&lt;p&gt;&amp;gt; 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.&lt;p&gt;&amp;gt; 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&lt;p&gt;&amp;gt; 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; ...&lt;p&gt;&amp;gt; ...we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification.&lt;p&gt;&amp;gt; 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...&lt;p&gt;&amp;gt; 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.</text></item></parent_chain><comment><author>dnautics</author><text>Not all of it is reasonable, at all:&lt;p&gt;&amp;quot;For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery&amp;quot;&lt;p&gt;Uh, you don&amp;#x27;t think the surgeon is going to demand a second BRCA test be done before performing the surgery?</text></comment>