More on the 23andMe Debacle

Article by Dale Ralph Meitzler


Another take on the 23andme case is found on in an article by Ryan Bradley titled “The curious case of 23andMe”. He states “The FDA approval process for medical devices is insane. Even the FDA knows it’s way too long and way too expensive.”

I have to ask what’s to approve about a bottle you spit in or a swab to wipe your cheek. This same technology has been used for years without the FDA getting involved.

Back in grade school’ I was in a study regarding how many children used tobacco. They had us put a sponge in our mouth, capturing our saliva, same technology, and they didn’t even have to get parental approval.

One thought on “More on the 23andMe Debacle

  1. Ryan Bradley is entitled to his opinion, though I would be interested in knowing the source for his claim “Even the FDA knows it’s way too long and way too expensive.” It is not the bottle or the swab, it is the labeling/intended use, that make the bottle and swab a medical device. If it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, then it is a medical device. Since tobacco use per se isn’t a disease (though it certainly lead to diseases), that product wasn’t a device. The lack of parental approval certainly wouldn’t pass muster these days.
    The Legal Genealogist has an excellent discussion on this issue – check it out.

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