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Adverse Event Clinical Trial using a 510K approved Device

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
After years of trying to find a home for our continuous temperature monitoring device, it has found a home with CAR-T and numerous pharma companies from the USA and EU. The FDA has demanded the CAR-T trials to use a preventive measure to document cytokine release syndrome (creates dangerous fever) which is an expected outcome of CAR-T treatment and indicates the therapy is working. The more soft tumor mass the greater the immune response which is somewhat paradoxical. The risk of identifying and responding to a fever from CRS is critical and a high% of patients die (based on the pharma companies data) when CRS is not detected early enough. So, the fever itself is a good indication but it does need to be controlled; this makes our device a perfect fit.

In our agreements, we discuss adverse event reporting. Our 510K indicates our device is usable by all people of all ages.

In the event of a reportable event, who and how should it be reported to FDA?


Involved In Discussions
You are required to submit a medical device report if your device caused or contributed to a patient death or serious injury. If your device functioned normally but the patient still died from the treatment, you would not be required to submit a report because your device did not contribute. The drug manufacturer will be required to report though. If I were you, I would review your risk management documentation and ensure your have done adequate analysis on use errors. You may get into the situation where the drug manufacturer claims that a foreseeable use error contributed to patient harm. In this case, it would be best to err on the side of caution and submit a report.
I'm not sure I'm following you. Your device will be used to measure drug efficacy, right? The pharma companies will sponsor the trials, which will be conducted under an IND? And this use is consistent with your cleared 510(k), so you won't need an IDE?

If all of the above is correct...

The pharma company will be required to report AEs occurring in their drug trial, by way of their IND. I don't think this will satisfy MDR requirements.

I would treat each AE as a "complaint" and investigate it like any other complaint, and then submit an MDR if your investigation determines one is warranted. (Your investigation might establish that your device didn't contribute, but I think you still need to investigate to establish this.) I would NOT have the pharma company submit an MDR report. However, the "device user facility" might feel obligated to report some of the events, although since your device is being used in a trial, they might not connect those dots. Regardless, if they submit an MDR, then I would deal with it just like any other MDR submitted by a user facility.

Make any sense?

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Yes, thanks! Our 510k is for all users and all ages. This specific IND involves a special classification of the user (soft tissue cancer patients). I do have some worries though. For example, its possible these users are prescribed Thiotepa, which makes skin more sensitive and can cause a rash - we have had a complaint for a rash and the root cause was Thiotepa use. We do list mild rash as possible side effect of use though.
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I think you might have some problems with intended use. There is a difference between "all users and all ages" and unspecified users and/or ages. You can get a device cleared as a "general" surgical tool for whatever type of surgery the surgeon chooses and/or as a tool for a specific type of surgery, which would of course be a subset of whatever type of surgery the surgeon chooses, but these are two different clearances. Have you run into this little regulatory quirk before?
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Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
No. One of the items in our SoWs with the pharma companies is regulatory assistance and I think this is going to come up.

I think it's logically snarly, but then I think the 510(k) is logically snarly, so big surprise. I actually ran into the same issue with an NB review of a Class III design dossier, but the discussion wasn't burdened with the notion of substantial equivalence, so it was considerably less snarly.

What I've worked out in my head is that it's about how aggressive your claims are, versus the data you have to support them. For example, when you tell surgeons a device is a tool for "whatever," you are essentially spinning a softer version of caveat emptor, in that the surgeons are (or should be) aware that the decision is on them, and that you don't have enough data to support safety and effectiveness of any specific use a surgeon might come up with. However, if you promote it for a more specific use, then you should have data to support that specific use, because then surgeons will think (in theory, like they really think about these things) that you do, and therefore do not think about whether it is likely to be a good idea. Plus, that specific use could be riskier than "whatever" use. In this case...cancer, high risk, usually a given.

The more practical question is when and how you might address this. I think you would like to actively promote use of the device to monitor efficacy in these types of trials? I don't think you are planning to promote it for this use in clinical practice? In any case, sounds like you might need an IDE. Next question is, are subjects at risk if your device doesn't turn out to be as effective in monitoring drug efficacy as everyone might have hoped, or is this one question that the trial will try to answer? If the former, full IDE, I would think. If the latter, maybe an abbreviated IDE, if you can find an IRB that won't just be hopelessly confused by the whole thing.
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