Why Is The FDA Regulating DNA Scans?

Jillian Bandes
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Posted: Jul 01, 2010 11:32 AM
Several companies have started selling little cotton-tipped cheek swabs that tell the customer what DNA irregularities they may suffer from. The FDA didn't take notice of this new product until one of the companies tried to strike a deal with Walgreens to sell the things at their stores. Then, the FDA decided to intervene -- because God forbid a company should sell anything even tangentially related to the medical field without regulators sniffing around.

As expected, Walgreens canceled the deal after the FDA warned the company that it may need pre-production approval, along with a medical device tax. Why were they able to do this now, given that the device has already been in production? Because, as John Derbyshire at National Review points out, the FDA simply hadn't caught on. The timing and method by which they choose to regulate is totally up to them.
What actually is a “medical device”? Answer: A medical device is anything the FDA declares to be a medical device.