I think understanding the "why" of the boards position is helpful, thanks.
(07-12-2014, 04:58 PM)SuperSleeper Wrote: ... But some are saying that if they sell you all the parts separately that can be used to make up a complete mask, a prescription isn't required. I have my doubts as to the veracity of that conclusion, and an attorney friend who has helped Apnea Board in the past agrees that an attempt to skirt the regs by selling parts separately could easily get the FDA involved legally. If FDA wanted to start enforcing the regs, they probably have enough wording in the current regs to justify the consideration of mask parts themselves to be integral parts of the masks and therefore prescription-required items. The thing is that they don't seem to be enforcing that right now... but they could at some point in the future.
I am not a lawyer. I believe what you describe is called "structuring." It is a legal concept where a series of transactions are done with intent to "skirt" regulations. Federal law forbids structuring in areas such as banking and firearms transactions... they would likely extend it to medical devices.
INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
07-21-2014, 05:37 AM
(This post was last modified: 07-21-2014, 05:37 AM by Moriarty.)
FWIW - I have never needed a prescription for any mask or mask parts I have bought at retail in Australia...
Even if it is legal, and it isn't, at least that I am aware of, in the US, if the Apnea Board moderators have a rule against it, then we need to follow those rules as members of this board. Just my 2 cents worth. I am glad it got posted here because I was not aware of the rule. Hope all of you have a blessed and safe week. Thank you all for this board and all the help and information we can get here.