The PGS is classified as a medical device because it is intended to inform users if they are at risk for a certain disease and can potentially be used as a diagnosis tool, according to the letter. Being classified as a medical device subjects the product to FDA approval before being sold to consumers.
The letter identifies false positives and false negatives from the PGS as potentially harmful for consumers, leading to a risk of patients inappropriately self-managing their healthcare.
While 23andMe submitted a 510(k)s for the PGS, the letter says the company failed to submit follow-up documents requested by the FDA, rendering the 510(k)s withdrawn.
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