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
FDA CPAP Rules
FDA CPAP Rules
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Machine: ResMed AirSense™ 10 AutoSet™ CPAP Machine with HumidAir™ Heated Humidifier |
Mask: AirFit™ P10 Nasal Pillow CPAP Mask with Headgear |
Additional Comments: Do enjoy occassional essential oil, preferably peaty and from Scotland. |
When its my time to go I want to die like my grandfather did, peacefully, in his sleep . . . not yelling and screaming like the passengers in his car.
Re: FDA CPAP Rules
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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 |
Re: FDA CPAP Rules
One thing to keep in mind is if it didn't require a prescription, it might not be covered by insurance.
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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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Re: FDA CPAP Rules
Try this link.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
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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(5) REMstar Autos w/C-Flex & (6) REMstar Pro 2 CPAPs w/C-Flex - Pressure Setting = 14 cm.
"Passover" Humidification - ResMed Ultra Mirage FF - Encore Pro w/Card Reader & MyEncore software - Chiroflow pillow
User since 05/14/05
"Passover" Humidification - ResMed Ultra Mirage FF - Encore Pro w/Card Reader & MyEncore software - Chiroflow pillow
User since 05/14/05