Ha ha ha! How true - we can spend millions on erectile dysfunction and hair loss, etc. but short change research for AIDS, cancer, OCF etc. It is, after all, a market driven society. Look on the bright side - now that we have conquered ED and hair loss and now the boomers are turning up with cancer so the heat is on the researchers now. We haven't accumulated all of this wealth and inheritences just to have our lives cut short. Like Dylan said back in the 60's "The times they are a changin""

The whole issue with the FDA is that people or companies wanting to sell medical devices in the US have to prove safety and efficacy before they are allowed to market them. It is to protect the US public.

It is a multidimensional issue - true, some components may have previous clearance, like the implant screw, but if there is a new manufacturing process involved then the biocompatibility testing has to be done over. Materials from the manufacturing process may have an adverse effect. Raw materials themselves are often confusing to manufacturers lacking regulatory experience, I actually encounter this a lot. They assume that because a certain material is FDA approved, that it can be used in the body but the truth is that the FDA only approves raw materials that are to be used in food containers, to insure that harmful substances are not leached out into the food.

The un-implantable device is still used in an "intact body channel" i.e. the mouth so biocompatibility would still have to be performed (although not to the level of standards that the implant would with blood, bone and long term exposure) . It is also indicated to "modify or alter the structure of the human body", i.e. stimulate the salivary glands so it meets the criteria of the definition of a medical device.

You could always move to Israel.

Doctors can do want they want (from a surgical perspective anyway) - if someone wants a sex change - that is not regulated by the FDA. And here again, they make big money on this procedure. It's an elective procedure the same as a face lift or boob job.

Comparing surgical procedures and medical devices and like comparing apples and oranges.

Be comforted in the fact that when you have procedures done, using medical devices, that they will safe and efficacious and not injure you.

I would ceratinly be happy to take them as a client and obtain their clearance to market or pre-market approval. I have well over 100 510K clearances in a wide variety of devices and applications.

510(k), by the way, refers to Section 510(k) of the Food, Drug & Cosmetic Act. The definition of a medical device can be found in Section 201(h)