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Documentation for selling Prescription Only Medical Devices

E

emiddle

#1
We have a class 2 medical device that is sold to medical spas and doctors. It is a laser used for aesthetic purposes. Each state also has their own regulations on who is allowed to use the device. So for example in some states the Dr needs to be within 5 miles of the facility while other states the Dr needs to be the one operating the device

1. Does a physical label need to be on the device. I feel there are conflicting stories
2. Does some labeling need to be in the owners manual
3. Do we need to collect documentation from each "buyer" or can we have them sign something on a sales agreement that says this device is for Rx use only and you should also look to your state laws? In many states the buyer will not be the doctor but the spa that the Dr is associated with.
4. Is there a FDA guideline on who can use a prescription device that trumps state laws? If so where is that guideline

thanks,
 
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M

MIREGMGR

#2
Re: Documentation for selling Prescription only device

4. Is there a FDA guideline on who can use a prescription device that trumps state laws? If so where is that guideline
FDA generally regards the FD&C Act as overruling conflicting state laws, but generally the states do not agree...and in any case, this only pertains to direct conflicts where the feds say go left and a state says go right. FD&C Act generally does not block states from having regulations that accomplish the same goal as the feds, but to a greater degree or extent; or regulations that accomplish some other goal that doesn't interfere with FD&C Act's purposes, whether it makes sense to FDA or not.

For instance: Louisiana state law says that Rx Only devices ("legend devices" in their law) may only be distributed to the end user by a state licensed pharmacist. This law was written to govern home use of prescribed devices by patients, and intended to prevent non-experts from dispensing them. (And maybe to provide some market protection for the pharmacists' organization.) The law failed to recognize that many professional-use-only devices used in hospitals are sold by specialist distributors directly to such hospitals under the blanket prescribing authority of the doctors who supervise and manage the hospital's medical activities. FDA's view is that the Louisiana law isn't consistent with FDA intent, but that that's not FDA's problem.

Your corporate lawyer should be your source of guidance on what to do in your situation. My experience in the past has been that companies in a position such as yours must conform to every different state's laws.
 
M

MIREGMGR

#3
Re: Documentation for selling Prescription only device

1. Does a physical label need to be on the device.
My view based on Warning Letter reviews is yes.

2. Does some labeling need to be in the owners manual
Clearly yes.

3. Do we need to collect documentation from each "buyer"
To satisfy FDA, you must have records that provide for each transaction to be linked to a prescription-order by a specific legally authorized medical professional.

...or can we have them sign something on a sales agreement that says this device is for Rx use only and you should also look to your state laws?
Yes, you should have such language on your sales agreement, but it's just informative. It has zero effect to shield you from legal obligations.

In many states the buyer will not be the doctor but the spa that the Dr is associated with.
It doesn't matter who the buyer is, at least in those states that do not regulate Rx device distribution. It does matter that you have a specific prescription-order from a licensed physician or other legally authorized prescriber, or a legally acceptable substitute, for every unit you distribute.
 
E

emiddle

#4
Re: Documentation for selling Prescription only device

Thank you. I still find it confusing because even in your example "Louisiana state law says that Rx Only devices ("legend devices" in their law) may only be distributed to the end user by a state licensed pharmacist."

We wouldn't be distributing to the end user but rather to the "state licensed pharmacist"

So I was looking for some guidance that shows us we are allowed to sell to the pharmacist as the guidance says "distributed by... healthcare professional"

So I am trying to find something that makes it clearer who we can sell it to. One way to read it is that if we had a doctor on staff, we could sell it to anyone (which obviously isn't the intent), or another way to read it is that we can not sell it to anyone because we are not a licensed pharmacist (in your example..which also isn't the intent)

Thanks
 
E

emiddle

#5
Re: Documentation for selling Prescription only device

This is great. Thank you. I guess, I am looking for the documentation on what a substitute would be for a "prescription". I know doctors are not writing a "prescription" to *buy* a machines. I think the "prescription" is for them to use it on the end user.

As an analogy only. It is like the manufacturer of a drug selling to the pharmacist, who eventually resells the drug to the person who has the prescription. The pharmacist doesn't have any prescriptions until such time as an end user walks in the door, but prior to that was able to acquire the drug...I realize that these may fall under a different rule set than devices. But I am trying to get some clarity on how to sell it, and what documentation we would need...or the "substitute" to the script...thanks
 
M

MIREGMGR

#6
Re: Documentation for selling Prescription only device

We wouldn't be distributing to the end user but rather to the "state licensed pharmacist"
My example was intended to illustrate the boundary of FDA's concern regarding state law conflicts, not to directly address your situation.

Aside from that, though, I'm bemused by your quoted comment. You sell only to aesthetic-spa buyers that have a state licensed pharmacist on staff to do the dispensing, and a state licensed physician to do the prescribing? Seems like that would be a smallish market. :)

So I am trying to find something that makes it clearer who we can sell it to.
Under federal law, you can sell to anyone once a state licensed physician has written a prescription to authorize that particular sale.

Under some states' laws, there may be restrictions on how the sales are made...in particular, the device might have to pass through the legal possession of a licensed pharmacist who reviews the prescription.

One way to read it is that if we had a doctor on staff, we could sell it to anyone (which obviously isn't the intent)
Not just not the intent, but also I think legally wrong unless the physician is licensed with prescription authority in the state where the sale will be made, and (in all states that I'm aware of) the physician has direct knowledge of the medical situation of the patient(s) and appropriately controls the forward-going use of the Rx device.

Lots of mail/internet/telephone sellers of Rx devices and substances have tried the we-have-a-doctor-of-our-own-he'll-write-a-prescription-for-anyone dodge. In every instance I've heard of, they were shut down or, if they pushed back, lost in court.

another way to read it is that we can not sell it to anyone because we are not a licensed pharmacist (in your example..which also isn't the intent)
Actually that is the intent of the State of Louisiana, and a few others.
 
E

emiddle

#7
Re: Documentation for selling Prescription only device

Thank you...sorry my description was off, the market isn't that big - but it is growing. Which are "medical spas".

So I know that lasers and other prescription medical equipment are being sold to these facilities. Are you saying that in each case a Doctor has to write a "script" and then each facility has to create a purchase order, just to buy the device (not even including the scripts that will have to be created for the medical spa to use the device). For some reason that just doesn't feel correct.

Does a hospital write a script every time they buy a device?

Sorry this all just seems a bit confusing
 
M

MIREGMGR

#8
Re: Documentation for selling Prescription only device

I am trying to get some clarity on how to sell it, and what documentation we would need...or the "substitute" to the script
The company for which I work sells Rx Only devices directly to hospitals. It's generally understood by FDA, if not necessarily by all states, that hospitals buy Rx Only, professional-use devices under the legal authority of the physician(s) that are legally responsible for the hospital's operations. That authority depends on the general understanding that the hospital in question operates according to generally recognized good medical practice and is continually staffed by licensed physicians and pharmacists. Thus the Purchase Orders that we receive from hospitals or their buying groups are traceable via that understanding to a legal authority.

My surmise--I haven't seen this legally developed anywhere--would be that a similar authority could exist on the part of an aesthetic spa if that spa is documented as operating according to generally recognized good medical practice, and operates under the continual on-site supervision of a physician. In effect, the spa would have to operate like a medical clinic.

Or, the purchase order to you could come directly from the physician, or could come from the spa and be accompanied by a specific Rx script.

That's my input. Keep in mind that you might be on stronger legal ground if you were getting this advice from your lawyer.
 
E

emiddle

#9
Re: Documentation for selling Prescription only device

Great. Thanks for your help. Yes I understand the lawyer maybe the best route. I like to do my due diligence first. I have found that lawyers and I both like the same thing...my money :)
 
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