FDA medical device regulation

[johnsands]

I live in Washington State, and I purchased some anesthesia vaporizers at a university surplus sale. I was going to sell them, but I saw that they have a sticker on the back which says:

"Caution: Federal Law restricts this device to sale by or on the orders of a physician."

you can see the sticker on the back of this one:

http://i31.tinypic.com/29mwt2e.jpg

Anyone know what this is about?

 

[FlyingRon]

Looks pretty self explanatory to me. Certain medical devices require prescriptions just like drugs.

 

[johnsands]

I actually found some information about the law that relates to this:

CFR - Code of Federal Regulations Title 21

specifically:
(b) The label of the device, other than surgical instruments, bears:

(1) The statement "Caution: Federal law restricts this device to sale by or on the order of a ____", the blank to be filled with the word "physician", "dentist", "veterinarian", or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device; and

(2) The method of its application or use.




However it appears to be intended to force manufactures who produce medical devices which do not include instructions for a laymen, and are not intended for use by laymen, to include the sticker, but I was unable to find any information which said people without medical licenses are not allowed to own, buy or sell the devices. Or what the penalties are if they do.

Like I said, I bought these from a state-run university, and they made no attempt whatsoever at checking if I had a medical license or anything.

I also do not know what the actual sticker is saying. Is it saying that a doctor can sell the device to someone without a medical license, but the person who buys it can't sell it, if so that seems weird.

 

[justalayman]

. Is it saying that a doctor can sell the device to someone without a medical license, but the person who buys it can't sell it, if so that seems weird.

it is saying that a doctor can sell the item or a doctor can prescribe the device so the retailer/wholesaler/ whomever can sell the product to the person the prescription was written for.

 

[johnsands]

The device is a anesthesia vaporizer, there would be no reason for it to be prescribed to a patient, since they would have to hook it up to a $4000 anesthesia machine, which they would have to know how to operate, and there would be no medical reason why a patient would need to anesthetize themselves, nor would they be able to.

 

[ecmst12]

So who do you think you would sell it to?

 

[FlyingRon]

Makes no difference. Lots of devices are so marked even if they aren't presumably intended for sale direct to consumers. That doesn't mean there aren't restrictions to their sale or use. I've got oxygen tubing marked "federal law prohibits dispensing without a prespcription. TUBING!

You can roll the dice and take your chances, but it is outright illegal to sell those to end users as medical devices for sure. If you are selling for other than lawful use, they may dredge up this to tack on to your other charges.

 

[Zigner]

I suggest you head back to the university and get your money back, as they should not have sold them to you in the first place.

 

[johnsands]

"I've got oxygen tubing marked "federal law prohibits dispensing without a prespcription. TUBING!"

FlyingRon, do you know what the penalties are if someone did dispense the oxygen tubing without a prescription? I would still like to see the actual statute where it actually says that it is illegal, because the only thing I could find relating to the text on the back of the device was CFR 801.109 (b)(1) which states that manufacturers must put the label on, and I also saw some stuff about the penalties, which all related to selling "altered or misbranded medical devices" but nothing which related to a laymen selling the devices.

Also, there are tons of vaporizers on Ebay, and I seriously doubt that all the seller are licensed physicians, but according to what I have seen, you are required to put the following disclaimer on an auction for any medical device:
FDA Disclaimer:

"The sale of this item may be subject to strict regulation buy the U.S. Food and Drug Administration and State and local regulatory agencies. If so do not bid on this item unless you are an authorized purchaser. If the item is subject to FDA regulation, I will verify your status as an authorized purchaser of this item before shipping of the item."

In other words, as far as Ebays legal department is concerned, it is legal as long as you sell it it to a licensed physician/dentist/veterinarian.

Which is why I wonder about the meaning of the label which seems to imply that only physicians can sell it or order it to be sold, but anyone can buy it from a physician, or from someone selling it on a physicians order.

"I suggest you head back to the university and get your money back, as they should not have sold them to you in the first place. "

According to the label, as long as a licensed physician or veterinarian ordered that the device be sold as surplus, then it was legal for them to sell it to me.

 

[justalayman]

eBay has nothing to do with this. eBay is merely a conduit. They can apply whatever rules they want and they can do so arbitrarily with no requirement as to when or if they must apply them.

They are the bit torrent of junk. The allow the passage but are not legally required to control it. They take actions to protect their asses.

According to the label, as long as a licensed physician or veterinarian ordered that the device be sold as surplus, then it was legal for them to sell it to me.

Sure, twist it however you want. Doesn't make it legal of course but you can claim whatever you want.

 

[xylene]

Durable medical devices sales restrictions are not enforced apart from context.

So unless you are going to use or sell these devices in part of making meth or some other illegal activity, it just isn't going to come up.