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?
Showing posts with label surgery and headphones. Show all posts
Showing posts with label surgery and headphones. Show all posts
Thursday, November 30, 2006
Headphones for Surgery
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?
Subscribe to:
Posts (Atom)