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FDA Medical Device regulations

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johnsands

Junior Member
I live in Washington State, and I purchased some anesthesia vaporizers at a university surplus sale. I bought them because they were only $5 at an auction, and I knew they had to be worth more even though I didn't know what they were. 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."

This is the exact same make and model that I have: Edit: I can't tell if the links are showing up properly :confused:, sorry if it's a mess.

http://www.medwow.com/used-vaporizer-for-anesthetics/draeger/vapor-19-1-halothane/393389148.item

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

http://cgi.ebay.com/Drager-19-1-Isoflurane-Anesthesia-Vaporizer-ISO-Vapes-/260635341211?cmd=ViewItem&pt=LH_DefaultDomain_0&hash=item3caf13b19b

I tried to find some information about the what the sticker might be talking about and I found the regulation 21 Code of Federal Regulations (CFR) sec. 801.109(b)(1) which says that medical devices which do not include instructions for laymen, need to have the sticker which I mentioned.

Here is a link: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.109

I also found some stuff in TITLE 21 > CHAPTER 9 > SUBCHAPTER V—DRUGS AND DEVICES of the USC.

But, I haven't yet found if it is actually against the law for people without medical licenses to possess these medical devices. It looks like the only law is the one which requires that manufactures put the sticker on it.

my questions are:
1) What exactly is the "Federal Law" which is referred to on the sticker?
2) Is it illegal for non-physicians to possess the devices?
3) Is it illegal to sell them?
4) If so, what are the penalties?
 
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