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To: Mr.Kups who wrote (6460)	2/23/1999 9:18:00 PM
From: Alan J. Levie	Respond to of 9824

Good question! I was wondering the same thing.

To: Mr.Kups who wrote (6460)	2/23/1999 9:24:00 PM
From: The Steve	Read Replies (3) \| Respond to of 9824

Mr. Kups, I have done so research on this a while back. The best that I could find was an article that stated that a Class I & II device, which is a non groundbreaking device, takes approximately 113 days (3.67 months) to get approved . This was the 1996 average though and there has been alot of reform in the FDA since then. They have hired more people and streamlined the approval process. I imagine this average has come down quite a bit. I also researched the FDA website and am pretty sure that it won't be a class III device. Basically, class III devices are devices that are totally new and never been used before. This is a EKG device. The device itself isn't new. The lower price and ease of use is. A class III device takes an average of 572 days for approval. As long as it doesn't get classified as this, the June date doesn't seem that far off. I really don't think it will be a class III device from what I read. It is only an average though and obviously, some take less time and some take longer. Anyway, whenever it gets approval, it's gonna make some good money. Here is the article I referenced and FDA website: amcity.com fda.gov

To: Mr.Kups who wrote (6460)	2/23/1999 9:34:00 PM
From: T A P	Read Replies (2) \| Respond to of 9824

Tracker will not take as long as FDA approval for drugs or new medical device implants as it is a non-invasive device.