RESMED gone wild - u need prescription to buy RESMED's mask

billbolton · Post by **billbolton** » Sun Aug 19, 2007 5:03 pm

goose wrote:So in conclusion - it seems that Resmed is asking that the FDA regulations be enforced,,,,

There is no hard evidence anywhere in this thread as to which manufacturer was involved in approaching eBay, despite the shoot-from-the-hip topic title chosen by the OP!

It seem fairly clear that all the suppliers have been nominating mask as prescription items with the FDA for a while, and they all have the same basic interest in the topic, so it could have been any one of them.

Cheers,

Bill

echo · Post by **echo** » Sun Aug 19, 2007 5:33 pm

after waaaaaay too much time searching the FDA website (I'll never make my morning meeting now!!... EDIT: Thanks Goose )... I found the following info:

Class I medical devices do NOT require a prescription, but Class II devices do.

The P&B "NASAL CPAP CIRCUIT" is listed as an Anesthesiology mask and therefore classified as Class I ( http://www.accessdata.fda.gov/scripts/c ... m?&ID=1480 ) and regulation number 868.5580 (http://www.accessdata.fda.gov/scripts/c ... R=868.5580)

Alternately their HH seems to be class II, but I couldn't determine whether it was a Class II Exempt device. (http://www.accessdata.fda.gov/scripts/c ... ?&ID=61968)

Similar to the P&B mask, the Spectrum FFM from Respironics is listed as Class I:
http://www.accessdata.fda.gov/scripts/c ... ?&ID=21775

The Hans Rudolph is a Class I : http://www.accessdata.fda.gov/scripts/c ... ?&ID=13319

For Resmed, all I could find were "non-vented masks" so i guess that's not it: http://www.accessdata.fda.gov/scripts/c ... m?ID=32832 ... maybe they are listed under another Manuf. name?

However Goose is right about the "Prescription use" box being checked on most of these if you look to the 501(K) Clearance report.... Also I noticed somewhere else on the FDA site (can't find the link back though) that if you go to another link about the CPAP mask, it goes the device classification description of the CPAP itself (which *is* a Class II regulated device).

So I dunno!!! I'm confused, tired, and don't care anymore, as long as the government leaves us alone! (which isn't likely to happen... I mean look at their control of even herbal and vitamin supplements!!! It's getting worse every year....)

echo · Post by **echo** » Sun Aug 19, 2007 5:48 pm

After some more digging...

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment by submitting Form FDA 2891, "Registration of Device Establishment," and list the generic category or classification name of the device by submitting Form FDA 2892, "Device Listing."

(emphasis my own)

And then if you look to this CFR 862-892, http://www.accessdata.fda.gov/scripts/c ... FRPart=868
both humidifiers (§ 868.5450) and masks ( § 868.5550 ) are exempt devices ....

So I think in summary any CPAP device classified with a code on THIS list does NOT need a prescription. However I cannot find device names like "Activa" or "Ultra Mirage" so I leave that up to some one <<looks around hopefully >> to figure out if those devices are classifed as 868.5550 or something else....

echo · Post by **echo** » Sun Aug 19, 2007 5:52 pm

OKAY I GIVE UP. CPAPs are classified as " 868.5905 Noncontinuous ventilator " and they are ALSO on the previous list...

http://www.accessdata.fda.gov/scripts/c ... r=868.5905

@#$@#$!@#!@#!!!#$*&*(^$&

I think they ESPECIALLY make it complicated so comsumers have NO IDEA WHAT IS GOING ON.

good night folks, this has been an informative and wholly confusing topic.

echo · Post by **echo** » Sun Aug 19, 2007 5:57 pm

Boy talk about spam (I'm soooo getting kicked off this forum)

THIS is the EXEMPTION list:
http://www.accessdata.fda.gov/scripts/c ... =868#start

Note the appearance of the mask (§ 868.5550 ) but not the HH. Sigh.

And I could NOT find a database listing what devices need a prescription.

Case solved??

Anyone... anyone... ??

goose · Post by **goose** » Sun Aug 19, 2007 5:57 pm

Thanks Echo -- appreciate the research time.
I think the overall conclusion that one can draw from this is that even the Feds have conflicting information on their site......
I don't think I'll revisit the FDA site anymore.....As I'm sure Echo found, it's a maze and once you get in, it's difficult to keep track of where you are

Typical Governmental goobly-gook......

Whatever - I have a prescription for my mask(s), so I'm not overly concerned, but it is a bummer that ebay won't list them (though I'd be pretty careful of anything I found on ebay -- you reallllly don't know the real "past" of whatever it is - medical or not).....

cheers
goose

echo · Post by **echo** » Sun Aug 19, 2007 6:14 pm

Oh yeah found one more thing... the Resmed and Respironics masks have been submitted to the FDA under the classification for a CPAP machine, wherease the P&B ones are listed as either anesthetic mask or oxygen mask (both exempt). So I guess that explains it... the manufacturers themselves put it in that classification. (historical reasons? $$$ reasons? P&B is non-US and the others are US?)

... As goose says even the Feds contradict themselves (um I agree with you, gotta say off the FDA pages!!!!!).

all very strange stuff I must say.

cpapernewbie · Post by **cpapernewbie** » Sun Aug 19, 2007 7:44 pm

billbolton wrote:
goose wrote:So in conclusion - it seems that Resmed is asking that the FDA regulations be enforced,,,,
There is no hard evidence anywhere in this thread as to which manufacturer was involved in approaching eBay, despite the shoot-from-the-hip topic title chosen by the OP!

It seem fairly clear that all the suppliers have been nominating mask as prescription items with the FDA for a while, and they all have the same basic interest in the topic, so it could have been any one of them.

Cheers,

Bill
]

Check CPAP-supply statement.

They are pressured by RESMED, as the only manufacturer that insist on prescription

_________________

CPAPopedia Keywords Contained In This Post (Click For Definition): resmed, CPAP, Prescription

billbolton · Post by **billbolton** » Sun Aug 19, 2007 8:18 pm

cpapernewbie wrote:[Check CPAP-supply statement.

They are pressured by RESMED, as the only manufacturer that insist on prescription

So what? There is no connection to eBay there!

oceanpearl · Post by **oceanpearl** » Mon Aug 20, 2007 3:10 pm

Simply a business decision that could affect the bottom line.
How many people here have actually purchased anything from Resmed for their own personal use. I WOULD GUESS NONE>

They stay in business because DME's buy their product. DME's get pissed if you buy from ebay. DME's complain to Resmed customer service. WHAT WOULD YOU DO IF YOU WERE RESMED??

Slinky · Post by **Slinky** » Mon Aug 20, 2007 3:32 pm

Actually, I was so pleased w/my Medicare purchased Resmed S8 Elite that I bought a Resmed S8 AutoSet Vantage. I had purchased a brand spanking new RemStar Auto W/C-flex (non-M series) and liked it, but when the chance rose to purchase a Resmed S8AutoSet Vantage I sold the RemStar to my son in law and bought the Vantage!!!

TXKajun · Post by **TXKajun** » Mon Aug 20, 2007 3:36 pm

Ya'll might check out this thread here: viewtopic.php?p=202230#202230

It's got a nice little note to ebay regarding masks not being prescription items.

Kajun

cpapernewbie · Post by **cpapernewbie** » Mon Aug 20, 2007 3:42 pm

TXKajun wrote:Ya'll might check out this thread here: viewtopic.php?p=202230#202230

It's got a nice little note to ebay regarding masks not being prescription items.

Kajun

_[/url]

That guy is posting from the UK

Australia and UK are not under the FDA

If we try to post anything, it will be removed before you even have time to talk about it. Now eBay is really strict and fast. No more selective targetting

Soon, probably very soon, you need a prescription to join this Forum

echo · Post by **echo** » Tue Aug 21, 2007 4:23 am

Just to reiterate, it was BOTH Resmed and Respironics masks that were listed as Class II medical devices with the FDA, therefore requiring a prescription.

The Purtian Bennett ones were listed as Oxygen or Anesthestethic masks, which are Class I and also exempt from FDA clearance, therefore requiring no prescription.

CPAP masks are NOT by default prescription. It just depends on how the manufacturer classifisied it with the FDA.

billbolton · Post by **billbolton** » Tue Aug 21, 2007 4:36 am

echo wrote:The Purtian Bennett ones were listed as Oxygen or Anesthestethic masks, which are Class I and also exempt from FDA clearance, therefore requiring no prescription.

Ventilation devices are in a different theraputic category to CPAP devices, and have different regulatory treatment, in most jurisdictions. PBs decision to classify its CPAP masks in that way has its own sets of consequences which PB may be in a position to manage differently from other CPAP suppliers....... or it may be thay they just misclassified them and FDA hasn't noticed yet.

Cheers,

Bill

Machine	Mask

Additional Comments: Airmini, Medistrom Pilot 24, CMS 60C Pulse Oximeter, ResScan 6

RESMED gone wild - u need prescription to buy RESMED's mask

Is it RESMED?