What do you know about the FDA??

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What do you know about the FDA?? You may remember my invention for delivering music during surgery. The final patent is almost in place and I had applied for an award that would provide money for marketing this device. To my shock and dismay, I did not make the final cut because I was told that anything used in surgery must have FDA approval. I was under the impression that because my device is non-invasive that there was no need for FDA approval. Now I know that this is not true. If one makes any sort of medical claim then FDA approval is necessary. Soooo, it’s a bit of a set-back, but also just a little bit more of a challenge, which I’m always up for!! Stay tuned!

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Headphones for Surgery

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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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