FDA takes issue with genetic tests from 23andMe, 4 other firms
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#1 Jun 11, 2010
Only devices that assist or treat the living organism should be within the sphere of FDA control. Simple analysis of genetic material does not and cannot affect the body: it is not a food, drug, corrective, or prosthetic, nor is the information itself inherently dangerous to the body in any way. There are NO "safety" or "effectiveness" concerns involved. The FDA is imputing "medical devicehood" where there is none and pulling regulatory out of the thin air that escapes its nether regions.
Why do we let bossy bureaucracies such as the FDA get away with this kind of power-grab? It's a lie that, in the absence of government law, the market is "unregulated." In fact, word-of-mouth advertising and the chilling effect of successful civil lawsuits regulate industries very well and have done so for centuries, without -- and sometimes despite -- governmental regulatory regimes.
#2 Jun 11, 2010
xxx "pulling regulatory out" should be "pulling regulatory AUTHORITY out"
#3 Jun 11, 2010
One last point: I have not seen the documentation for the tests in question, but a smart manufacturer would have included disclaimers warning about false positive indications and other sources of misinterpretation of the test results by consumers, along with the advice that consumers always consult with their physicians before taking any kind of action based on test results. As long as this cautionary note is given, then the responsibility for whether and what to do about the test results lies entirely with the consumer and his or her doctor -- AS IT SHOULD -- and is little or none of the government's business, much less the proper object of "medical device" regulation.
Just out of curiosity, must home pregnancy tests be FDA approved as "medical devices"?
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