The issue for Apnea Board is that:
1. CPAP machines and associated parts are classified as "Class II Medical Devices" (prescription-required) by the FDA.
2. To legally transfer Class II Medical Devices, there must be two items that the seller must have--
A) An Official DME license and
B) A copy of the patient's prescription on file for that device.
The burden of the law falls to the seller of a CPAP machine, not the buyer. If you can get a seller to sell you a machine without one or both of the above items, fine. They won't come after you. But start
selling a large inventory of CPAP machines without both of those items, and you'll likely get onto the FDA radar screen. And there is no distinction in the law between
new and
used medical devices. The law applies to all of them. The specific regs that require those 2 items are a
distribution regulation, not a
manufacturing regulation (the FDA regulates both). And, there are two areas of jurisdiction in the laws - the federal regs (primarily FDA) and each individual state's regs (a myriad of laws that vary by state).
That said, FDA enforcement action, (especially on the secondary used CPAP market) is pretty lax, perhaps even non-existent (at this time). There's not much legal risk to you as a patient when you're buying one without a prescription, nor is there a legal risk to the patient if the seller doesn't hold a current DME license.
Because it's a clear violation of law to sell CPAP machines (or their component parts) without a DME license or the patient's script, Apnea Board isn't willing to take the risk of being on the FDA's radar screen as a "
facilitator of an illegal sale, trade or transfer of regulated Class II Medical Devices". It's not the
buying part that gets you in trouble, it's the
selling part - and that's why we have a forum rule that states "
No member may use their forum account to solicit or facilitate the sale, trade, or transfer of any prescription-required items..." And this applies to everyone here, regardless of location-- as our rules state: "
Apnea Board is based in the U.S. and must comply with U.S. regulations and laws regarding prescription-required items, regardless of where our members are physically located."
If you can buy via Craigslist or any other person-to-person source, more power to you. However, if you have one to sell, you are in that case "the seller" and those FDA regs would apply to you. If Apnea Board were to allow an unlicensed seller to advertise a Class II Medical devices for sale, trade or transfer using their forum account, we technically could be in violation of the law, since that could be perceived as "facilitating" an illegal sale.
We'd like Apnea Board to remain online, of course. And if for some reason an over-zealous FDA regulator decided to come after us for facilitating an illegal sale, we quite simply would have to close the doors here, since we have no budget to fight any sort of legal battle.
Of course, we've had folks say "If it's illegal, then how come
http://www.CPAP-whatever.com is selling CPAPs with no prescription required?" I would have to refer you to the owners of that store or website. They've chosen to violate the law. It's their business, not ours. But just because a few people are out there violating the law is no reason to allow Apnea Board to be used to violate the law. The childish "everyone else is doing it" defense will not hold up in a court of law... trust me on that.
Some folks don't like that, but we're actually protecting the very existence of this forum and website. While we may nor may not be "caught" if someone uses their forum account to do such things - we are NOT willing to take that risk. If you want to sell Class II Medical Devices without those two requirements (DME license & prescription), then go for it-- just don't use your forum account here to do it or you risk being banned.
I've had people say "
It's no big deal to allow it here, it happens on other forums all the time!". My answer is always the same -
it's easy to say such things when it's not your own legal existence that's on the line. Go out and purchase a $1 million legal defense insurance policy to protect Apnea Board in case the FDA comes after us, and then we might consider allowing it. But first you'd have to convince an insurance company that we're not doing anything illegal when we allow prescription-required items to be sold here without a DME license or patient prescription. Good luck with that part.
