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!
Friday, January 05, 2007
What do you know about the FDA??
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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