21 CFR part 808 can clarify a lot in that context.You should seek the advice of an attorney as there may be local statutes that prohibit the use of uncleared devices.
21 CFR part 808 can clarify a lot in that context.You should seek the advice of an attorney as there may be local statutes that prohibit the use of uncleared devices.
From the FD&C Act: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.
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.
SEC. 502. [21 U.S.C. 352] defines what constitutes device misbranding.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.
Is this perhaps a grey area?
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.
Are you presenting this in relation to the OP or as a general interest?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.
assuming there are no more than five of them.