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What that pesky “FDA approval” actually means

If you thought that the “home use laser whatever ” was safe to you, think again. This is what FDA approval means for stuff inserted into your body! And don’t be surprised if the laser used on your sun spots leaves you with larger, permanent spots, of a different color.  It seems to me that people can be incredibly blase when it comes to their own bodies. You would not buy a used car from people like that but you will let them do permanent make-up (tattoos), use high energy laser beams on your dear skin and test their new theories on your body.



From the New York Times

May 4, 2019. Opinion
….”Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “updated” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. Eight years ago the Institute of Medicine advised the F.D.A. to abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested.”….

Read the whole article at

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