Due to recent changes within the FDA regulations, we are making one small change to further clarify our rules.
One line is changing, from this:
Quote:Prohibited Category 2: Solicitations offering prescription required items (such as CPAP machines or masks) for sale or trade.
Quote:Prohibited Category 2: Solicitations offering prescription required items (such as CPAP machines, humidifiers, masks or mask parts) for sale, trade or transfer.
The whole reason for this slight change is the poorly worded and obscure FDA regulations that came out in 2009. I don't have all the links handy but a year ago or so I read through all the applicable governmental laws and regulations from FDA.gov and other websites regarding Class II Medical Devices and in one section, it appears as though masks (and/or mask parts) are now considered Class II Medical Devices (requiring a prescription). Then another section seems to indicate that they might be exempt from that classification.
The point is, we really have no clue or clear direction from the FDA or other regulatory agencies with regard to how we're supposed to interpret these new laws. They have simply been silent. This is why many DMEs have taken the safer route of requiring prescriptions for CPAP masks and to a lesser degree, mask parts. For better or worse, Apnea Board is going to take the safe route also for masks and mask parts and any other parts that are likely to be (or could be) considered Class II Medical Devices or Class II Medical Device parts (because such parts are integral to the operation of a CPAP machine).
This revised policy makes it against our rules to offer a CPAP mask or mask parts for sale, trade or transfer anywhere on the forums.
Apnea Board is essentially an information-sharing and educational website and forum. We are not a commercial entity. We exist for the benefit of sleep apnea patients primarily and not for the benefit of commercial entities or those who wish to engage in commercial activity (like selling or trading CPAP mask parts online).
I'd also like to thank our Moderator, Monitors & Master Members who help to shape our rules and policies. They were very helpful in providing solid advice concerning the implications of how these new regulations might affect our forum operations.
If anyone has any questions concerning this policy, free free to ask here in this thread.
Thanks for your understanding.
Apnea Board Administrator