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Hospital-Developed, In-House Device - FDA Clearance?

Ronen E

Problem Solver
Staff member
Super Moderator
#12
I would have thought that as long as the hospital is not introducing the device into interstate commerce, that FDA has no authority to regulate it.
From the FD&C Act:
CHAPTER III—PROHIBITED ACTS AND PENALTIES
PROHIBITED ACTS
SEC. 301. [21 U.S.C. 331] The following acts and the causing thereof are hereby prohibited:
(...)
(g) The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
CHAPTER II—DEFINITIONS 1
SEC. 201. [21 U.S.C. 321] For the purposes of this Act—
(a) (...)
(2) The term ‘‘Territory’’ means any Territory or possession of the United States, including the District of Columbia, and excluding
the Commonwealth of Puerto Rico and the Canal Zone.
SEC. 502. [21 U.S.C. 352] defines what constitutes device misbranding.
 
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JeantheBigone

Quite Involved in Discussions
#13
I'm having difficulty applying the term "manufacture" to a single device which the hospital created for its own use.

To use an analogy, if in the course of treating a patient, a physician modifies an airway management device by attaching a hose to it to create a makeshift "device," FDA would not try to regulate that "device." If on the other hand the physician were to develop a design that is based on the concept of attaching a hose to an airway management device in order to market it, that would clearly be regulated.

Is this perhaps a grey area?
 
#14
Is this perhaps a grey area?
Maybe more like the line between the two clear extremes has the potential to get blurry.

Many physicians who develop devices in order to market them start by using their patients as guinea pigs. So one line that is potentially blurry is the one that falls between a one-off solution for the purpose of treating a particular patient and experimenting for the purpose of developing a marketable product.

Another is the difference between profiting from sales of a device and increasing profits by reducing costs. If you can make a device yourself, why buy from a manufacturer? If it is cheaper to make it yourself, and you will get paid the same amount for whatever procedure you use it for, then you would essentially be profiting from the use of your device.

Also, if you have no data on the safety and effectiveness of your makeshift device, where is the line between treatment and experimentation? At what point do you need IRB approval, informed consent? Most patients would not expect to be treated with any device not cleared or approved by FDA.

Whether FDA would try to regulate any of this is probably moot, since FDA has no way of knowing when physicians do this sort of thing.
 

OccamMan

Starting to get Involved
#15
If on the other hand the physician were to develop a design that is based on the concept of attaching a hose to an airway management device in order to market it, that would clearly be regulated.

Is this perhaps a grey area?
Maybe more like the line between the two clear extremes has the potential to get blurry.

Many physicians who develop devices in order to market them start by using their patients as guinea pigs. So one line that is potentially blurry is the one that falls between a one-off solution for the purpose of treating a particular patient and experimenting for the purpose of developing a marketable product.

Another is the difference between profiting from sales of a device and increasing profits by reducing costs. If you can make a device yourself, why buy from a manufacturer? If it is cheaper to make it yourself, and you will get paid the same amount for whatever procedure you use it for, then you would essentially be profiting from the use of your device.

Also, if you have no data on the safety and effectiveness of your makeshift device, where is the line between treatment and experimentation? At what point do you need IRB approval, informed consent? Most patients would not expect to be treated with any device not cleared or approved by FDA.

Whether FDA would try to regulate any of this is probably moot, since FDA has no way of knowing when physicians do this sort of thing.
This is a fairly unique device, that's tightly controlled to performance standards during use through multiple independent systems. There's no off-the-shelf equivalent for various reasons. I suspect that for any device this is a gray area, and for this device in particular there's a lot of unusual stuff, so probably next step is to chat with regulatory lawyers for an opinion. Thanks everyone for the info!
 

Ronen E

Problem Solver
Staff member
Super Moderator
#16
I'm having difficulty applying the term "manufacture" to a single device which the hospital created for its own use.

To use an analogy, if in the course of treating a patient, a physician modifies an airway management device by attaching a hose to it to create a makeshift "device," FDA would not try to regulate that "device." If on the other hand the physician were to develop a design that is based on the concept of attaching a hose to an airway management device in order to market it, that would clearly be regulated.

Is this perhaps a grey area?
Are you presenting this in relation to the OP or as a general interest?

You say "a single device", but it's unclear from the OP that that is the case. Just as another perspective, the MDR uses the term "industrial scale" (which is vague, but better than nothing) to draw some line between mass production and production involving a not-large number of units (definitely >1) that still justifies some sort of orderly compliance. I was thinking about the OP more as falling in that non-industrial (but >1) realm.

My other issue with your presentation is with "market it". This is a term not in the relevant legislation, so it complicates the discussion more than necessary. The scope of this specific discussion has been initially and intentionally a domain that is clearly grey in the context of "market" - in-house hospital make/use. It's not "marketing" in the everyday sense because there's typically no sale and no shipping, but nevertheless the scale can be notable and the need for regulation is not obviously dismissible because of a potentially "serial" nature and the potential effect on multiple patients.
 

JeantheBigone

Quite Involved in Discussions
#17
Are you presenting this in relation to the OP or as a general interest?

You say "a single device", but it's unclear from the OP that that is the case. Just as another perspective, the MDR uses the term "industrial scale" (which is vague, but better than nothing) to draw some line between mass production and production involving a not-large number of units (definitely >1) that still justifies some sort of orderly compliance. I was thinking about the OP more as falling in that non-industrial (but >1) realm.

My other issue with your presentation is with "market it". This is a term not in the relevant legislation, so it complicates the discussion more than necessary. The scope of this specific discussion has been initially and intentionally a domain that is clearly grey in the context of "market" - in-house hospital make/use. It's not "marketing" in the everyday sense because there's typically no sale and no shipping, but nevertheless the scale can be notable and the need for regulation is not obviously dismissible because of a potentially "serial" nature and the potential effect on multiple patients.
My post was addressing the OP. There was not enough information to tell whether there is one single device or more than one of the same type, but it sounded like one single device. There also isn't enough information to tell how the device was developed etc., so I used an example from my experience.

After looking into this a bit more it seems like it might be a candidate for the Custom Device Exemption, as it is "is not made generally available in finished form through labeling or advertising," assuming there are no more than five of them.

Definitely time for someone to take a closer look who has access to all of the needed information.
 

JeantheBigone

Quite Involved in Discussions
#19
As I understand it, it's "either or" but not both. If can be up to five devices customized for the use of one physician, or up to five devices customized for one patient.
 
#20
That makes sense too. However, I'm pretty sure this applies to a manufacturer making a customized device for a physician (fill a "custom" order), not to a physician making them for his own use in his own practice.
 
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