prescriptions

[JaVelin]

Lots of stuff is FDA approved and doesn't requre a prescription. The only other thing I can think of is that CPAP does nothing for central apnea and how is a lay person to tell which they have? if they have both they may only be fooling themselves into thinking thier self treatment is working then they fall asleep driving anyway.. would suck if it was a train they were driving for example so maybe the government wants the data so they know in the end how wide spread this is and to ensure hazards like this are avoided?

Nobody has mentioned the FDA. The laws that are enacted by our Congresscritters to establish the FDA specify that anything that is intended to diagnose, treat, etc, etc any disease or condition must be approved by the FDA. (Drugs like aspirin are in a class of excpetions that were in use before whatever date and are considered "grandfathered," but not necessarily approved.)

So, xPAPs are required by law to get FDA approval. (Not even going to any arguments about what OUGHT to happen.) That's the way the law reads at this time, as I understand it. Getting FDA approval of a devise is expensive. (Approval for drugs is even more expensive, though.) I think that that factor somehow plays in to the "prescription only" status of the devices.

JMHO.

[Julie]

If your PSG showed few to no centrals, then why imagine you suddenly have any? Plus, if you're using the software, even though centrals are not recorded directly, you can tell if everything else is going right (or wrong) and act accordingly. Kind of a silly business really about the government.

[JaVelin]

Well you have to have a machine already for that, which means you already have a prescription right?

If your PSG showed few to no centrals, then why imagine you suddenly have any? Plus, if you're using the software, even though centrals are not recorded directly, you can tell if everything else is going right (or wrong) and act accordingly. Kind of a silly business really about the government.