Tag: 510(k)

A Note to Our Customers Regarding the FDA

By Anne Wojcicki Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to market the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers in the US. This is also the first-time ...

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What The FDA Decision Means For 23andMe Customers

What does getting this marketing authorization mean for existing and future customers? As the first direct to consumer genetic test to complete the regulatory pathway, 23andMe’s Bloom Syndrome Carrier Status test was given marketing authorization through the de novo pathway. This is the first ...

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23andMe Takes First Step Toward FDA Clearance

Today 23andMe announced that we’ve submitted our first round of 510(k) documentation to the U.S. Food and Drug Administration (FDA). The application provides a detailed description of our Personal Genome Service®, extensive data supporting the performance of our technology, and comprehensive discussions of ...

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