FDA CPAP Rules

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
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40 Winks
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FDA CPAP Rules

Post by 40 Winks » Tue Nov 10, 2015 5:05 pm

Can anyone inform me how to get the FDA regulations regardings CPAP sales? I've just spent a half an hour on the FDA website to no avail ! ! !

It's probably right there in front of my face but . . . .

I'm looking for official guidance on what requires a prescription and what doesn't.

Thanks in advance, 4W

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flightco
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Re: FDA CPAP Rules

Post by flightco » Tue Nov 10, 2015 5:16 pm


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flightco
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Re: FDA CPAP Rules

Post by flightco » Tue Nov 10, 2015 5:21 pm

One thing to keep in mind is if it didn't require a prescription, it might not be covered by insurance.

_________________
Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier
Mask: Wisp Nasal CPAP Mask with Headgear - Fit Pack
Additional Comments: Also Sleepyhead, P10, F10 and Amara View

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Wulfman...
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Re: FDA CPAP Rules

Post by Wulfman... » Tue Nov 10, 2015 5:23 pm

40 Winks wrote:Can anyone inform me how to get the FDA regulations regardings CPAP sales? I've just spent a half an hour on the FDA website to no avail ! ! !

It's probably right there in front of my face but . . . .

I'm looking for official guidance on what requires a prescription and what doesn't.

Thanks in advance, 4W
Try this link.
It's from a thread from years ago where the forum member "tomjax" (who was a pharmacist) addresses prescriptions and "orders".

viewtopic/t108859/viewtopic.php?f=1&t=1 ... er#p118897

Then, do a Google search on "what medical devices require prescriptions or orders"

Edit: I found a few other links in case they may shed a little more light on your question.

http://www.fda.gov/RegulatoryInformatio ... 072747.htm

https://www.cms.gov/Outreach-and-Educat ... 905709.pdf

http://www.alaskasleep.com/blog/cpap-pr ... n-for-cpap


Den

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