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You probably remember that I am in the process of creating some special headphones for surgery. The patent is almost finalized but recently, I hit a little bump in the road. Seemingly out of the blue, it was brought to my attention that I would need FDA approval. At first I though “that can’t be right” but the more I have investigated it, the more I have found that it does seem to be true! It seems that if you’re making any sort of medical claim about a device, you must have FDA approval, whether it’s an invasive device or not. Interesting, eh?

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