FDA's 23andMe Decision Included First-Ever Opt-In Page Requirement

By Beth Wang / April 24, 2017 at 2:16 PM
FDA's recent high-profile clearance of genetic health risk tests by 23andMe brought with it a first-ever requirement that a sponsor create an opt-in page on its website -- previewing what potentially could reappear as the agency looks to exempt other GHR tests from device pre-market reviews. The opt-in page requires consumers to acknowledge before receiving test results that they understand genetic information can cause anxiety and the disease being reported may not have an effective treatment or cure. The page...


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