Does an ?Rx Only? medical device require an actual medical license from the buyer?

B

bncrowder

#1
[FONT=&quot]Newbie here, and I seem to be missing something. Does an ?Rx Only? medical device actually require a medical license from the buyer? For example I have run across numerous online retail stores where a Nasopharyngeal Airway is available for sell to the lay person without a medical license. I know the packaging has ?Rx Only? on it or the "Caution: Federal law..." statement, so how are these companies selling this device without requiring a medical license, or prescription, to be submitted by the buyer?[/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]My company wants to sell Nasopharyngeal Airways, but I want to make sure we are following regulation. [/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]Thanks for your help.[/FONT]
 
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Ronen E

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#2
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

Apparently someone is not following the law.
 
M

MIREGMGR

#3
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

"Rx Only" of course is US FDA usage only.

The permitted short form "Rx Only", and the corresponding full statement language "?Caution: Federal law restricts this device to sale by or on the order of a physician? (or other legally permissible prescriber), are both used in US law and regulations to indicate that the device so labeled is subject to one of two conditions: either it may not be sold or otherwise dispensed to a lay person except in response to a prescriber-signed order, or it is not suitable for lay use and is only to be sold to a health care providing organization that is under the legal supervision of one or more physicians, for use on patients where the end use is under the direct or indirect supervision of a physician or other individual who has appropriate prescribing authority for the item in question.

There is no basis in law or FDA regulations for a device labeled "Rx Only" to be sold directly to a lay person without a script.
 
B

bncrowder

#4
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

MIREGMGR,

First off thank you for your reply! My follow up question is in regards to the 510(k) associated with the above mentioned device, or other devices for that matter. If the 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary, but the device still has "Rx Only" on its packaging, can it be sold as an OTC, without a script?

Also, where does one find the 510(k) summary if it is not available on the FDA 510(k) search database?

Thank you!
 

chris1price

Trusted Information Resource
#5
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

Hi, you may want to double check, but Nasopharyngeal airways (BTQ, 868.5100) are class 1 and 510(k) exempt.
 
B

bncrowder

#6
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

Hi, you may want to double check, but Nasopharyngeal airways (BTQ, 868.5100) are class 1 and 510(k) exempt.
Yes, you are correct, but I do see a few 510(k)s out there for product code BTQ from the 90's and 80's, but I cannot find a summary for them to show the indication for use, "Prescription" and/or "OTC." Man, this leads me to another confusing question, if they are 510(k) exempt, then why did some companies submit 510(k)s for them? I am guessing the exemption came later....
 
B

bncrowder

#7
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

Yes, you are correct, but I do see a few 510(k)s out there for product code BTQ from the 90's and 80's, but I cannot find a summary for them to show the indication for use, "Prescription" and/or "OTC." Man, this leads me to another confusing question, if they are 510(k) exempt, then why did some companies submit 510(k)s for them? I am guessing the exemption came later....
I just answered my own questions:

"Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996."

Lots to learn here!
 

chris1price

Trusted Information Resource
#8
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

I used to work on oropharyngeal airways which had the same issues, they were originally class 2 and required a 510(k). They were reclassified in 1999 (i think) and made 510(k) exempt.

Or maybe it was 1996 - a long time ago now!
 

mihzago

Trusted Information Resource
#9
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

most of the submissions earlier than year 2000 or so, do not have 510(k) summaries, many don't even have a clearance letter posted. If you really need to see what's in those summaries, consider submitting an Freedom of Information Act (FOI) request.

Some devices have Rx and OTC designation at the same time because there maybe separate components to a device with one being OTC and others Rx. For example some tests may be OTC (the test application part), but the results and analysis is Rx.
Some software applications are also divided that way, for example diabetes management. The app portion with the educational materials, entry of blood glucose measurements and some other basic functionality may be OTC, but the more expanded functionality including analytics, etc would be for professional use only.

Another thing about Rx is that it does not have to be a physician. I've seen many 510(k) that will simply list a healthcare professional (e.g. licensed or trained to perform certain activity)
 
M

MIREGMGR

#10
Re: Does an ?Rx Only? medical device require an actual medical license from the buyer

If the 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary, but the device still has "Rx Only" on its packaging, can it be sold as an OTC, without a script?
Legal enforcement of rules governing sales of prescription devices is a state matter. In every state legal system with which I'm familiar, it is illegal to sell a device that is labeled "Rx Only" except by order of a valid prescription; and the status and content of a 510(k) associated with that medical device is irrelevant and does not / cannot override how the device is labeled.
 
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