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Medical Devices and the FDA

Posted by Ed Davis, DPM on 6/25/04 at 22:21 (153948)


ESWT machines are class 3 devices while renal lithotripsy machines, similar machines but more powerful and applied to a vital organ, class 2. Is there any doubt why ESWT is hard to obtain and expensive in the US after reading the above article?

Re: Medical Devices and the FDA

Bill, Jr on 6/28/04 at 14:42 (154092)

Dr Ed,

ESWL machines are class 2 with special controls because they have been used in the US almost 20 years and their effects are fully understood. I am sure that ESWT devices will be reclassified in good time.

The problem I see is that insurance companies continue to believe that ESWT doesn't work. They cite Buchbinder and other articles to support their case. As far as I can tell, it really doesn't matter how ESWT machines are classified since insurance companies continue to deny coverage.

Let's work on the insurance companies. Once they are on-board, we can work on the FDA.

Re: Medical Devices and the FDA

Ed Davis, DPM on 6/28/04 at 22:26 (154127)

I understand your point. There are quite a few manufacturers in Europe who would love to get their machines into the US, only 3 have spent the money to get their machines into the US. The hurdles and cost for a class 3 device are significantly greater than for a class 2 device.
Less choice of machines = less availability. Greater availability means more citizens will obtain ESWT which in turn would place more pressure on insurance companies. We can spend much time discussing this but the best advocates for ESWT are the patients who are delighted that they were cured without painful surgery.