Clinical trial - Medical device product not cleared (without FDA approval) in a drug trial

#1
Hi all,

I need your help again!
It is possible to use a medical device product not cleared (without FDA approval) in a drug trial.
We have a client that will perform a clinical trial and want to use our product (a software stand alone) to process the results of the trial but our product is not approved yet.
Thank you
 
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Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#3
No. One variable at a time. For an IDE or IND the only exception I have seen is using an approved device for off label use. For example, our surgeons in the surgical procedures wanted to use hemostats to help move a nerve into a position to wrap a cuff around it. Surgeons have some leeway in the way they are allowed to use tools in their protocols.

You first need to demonstrate singularly to the FDA your device is safe and effective for its claims.

Any IRB would suggest high risk and thus FDA oversight.

I worked at the Dept Veterans Affairs and managed several IDE studies. Almost every PhD had the IRB review require FDA oversight and a master file submitted to the FDA. They could consent a population to use a non approved drug but you cannot legally consent to also an unapproved device as well. This would require your own study to demonstrate effectiveness and safety before used in conjunction with the drug.
 
Last edited:

Watchcat

Trusted Information Resource
#4
Yes, it is possible to use a medical device not legally marketed in the US in a drug trial.

It is also possible to use one in a drug trial conducted at US sites.

If what you meant to ask is how do you legally conduct a clinical trial at US sites when that trial requires use of a device that is not legally marketed in the US, the answer is that you need to have an approved IDE.
 

Marcelo

Inactive Registered Visitor
#5
Hi all,

I need your help again!
It is possible to use a medical device product not cleared (without FDA approval) in a drug trial.
We have a client that will perform a clinical trial and want to use our product (a software stand alone) to process the results of the trial but our product is not approved yet.
Thank you
So, you mean that the device is a combination product and thus they would trial the device/drug? Or that it's a drug product, and for some reason they want the use the device?

The answers might be different depending on the situation (when I answered before, I was under the impressions that they were separate).
 
Last edited:

Watchcat

Trusted Information Resource
#6
For an IDE or IND the only exception I have seen is using an approved device for off label use. For example, our surgeons in the surgical procedures wanted to use hemostats to help move a nerve into a position to wrap a cuff around it. Surgeons have some leeway in the way they are allowed to use tools in their protocols.
If it was the surgeons who wanted to do it this way, instead of the sponsor wanting them to do it, I don't know that I'd call this an exception to the IDE, maybe more like outside of its scope. But maybe you are talking about a sponsor-investigator? (You say "their" protocols?)

Any IRB would suggest high risk and thus FDA oversight.
I'm afraid "any IRB" is something of a stretch. :( But I don't think IRBs would need to worry about the risk, since, as far as I know, there is no NSR exemption from the IND regulations? In that case, since the drug is also investigational, the study would require FDA oversight regardless of the level of risk of the device, don't you think?

I worked at the Dept Veterans Affairs and managed several IDE studies. Almost every PhD had the IRB review require FDA oversight and a master file submitted to the FDA.
I've worked with federally funded trials, sponsored by federally funded organizations. I think they tend to hold themselves to somewhat different standards than are typically found in the industry. They may also operate under various policy and/or legal constraints that are not applicable to trials sponsored by industry.

You first need to demonstrate singularly to the FDA your device is safe and effective for its claims.
You mean before using it in a trial? I wouldn't think so. That's what you need to demonstrate in order to market it.

They could consent a population to use a non approved drug but you cannot legally consent to also an unapproved device as well.
I'm not aware of this prohibition. Is it part of the FD&C Act, or some other law?
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#7
You make some good points. My work in Cleveland was mostly around nerve cuff and muscle stim for amputees and exoskeletons for SCI. Also all of our studies required a master file approval and FDA IDE rules.

Surgeons meet with the investigators and create a surgery "plan". How they plan to implant or explant the device. Just because a tool doesnt exist to hold a nerve in place to wrap a cuff around it doesnt mean the surgeon cant plan to use any other to perform that function. But the plan must be reviewable.
 
Last edited:

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#9
Oh like bringing their cell phones (Unsterilized) into the OR and taking selfies with the patient? :)
 
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