Regulatory Open Forum

A researcher is evaluating an FDA-regulated drug (has IND) for seizures. Part of the assessment is seeing if the drug helps prevent seizures over night (while sleeping). Can they use a CE-marked medical device in the research study to determine if the study drug is working (monitors for seizures) if the CE-marked medical device isn’t the actual device under investigation (they’re just using it for what it was approved for in the EU, but it doesn’t have market clearance in the US)?

My thought is “no”. For one: how is it being shipped without an IDE?

The study team says it has a breakthrough designation in the US. But if it is a breakthrough device then that would mean the device has to be used in an investigation, right? To test the device safety and effectiveness? But in this case they are only using as if it were already on the shelf and legally marketed.

What’s wrong (or not wrong) with this scenario?


Tamiko

Tamiko, yes, if the device is not legally marketed (e.g. not yet 510(k) cleared) then it is considered investigational and must be managed as such. Another jurisdiction's approval (CE Mark) has no acceptability in the US. 21 CFR 812 must be followed for investigational devices, noting that there is differentiation between Significant Risk and Non Significant Risk investigations (plus they're are some that are exempted). Additionally, there are streamlined pathways for using investigational devices within drug investigations, i.e. FDA will allow them to be studied together under the IND, but sufficient information must be specified within that filing (consistent with 21 CFR 812).

Further note that device breakthrough designation does not require clinical data and does not mean that any is ultimately required, since not all devices require clinical data for clearance (Class II). This is quite different than breakthrough designation for drugs (and is a common misunderstanding).

Hope that helps; this is a complicated topic and just scratching the surface here - feel free to message me directly for further discussion!

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Jonathan Amaya-Hodges
Director, Technical Services
Sharon MA
United States
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Original Message:
Sent: 12-May-2023 00:49
From: Tamiko Eto
Subject: Can a CE-marked medical device be used on US patients w/o FDA approval?

A researcher is evaluating an FDA-regulated drug (has IND) for seizures. Part of the assessment is seeing if the drug helps prevent seizures over night (while sleeping). Can they use a CE-marked medical device in the research study to determine if the study drug is working (monitors for seizures) if the CE-marked medical device isn't the actual device under investigation (they're just using it for what it was approved for in the EU, but it doesn't have market clearance in the US)?

My thought is "no". For one: how is it being shipped without an IDE?

The study team says it has a breakthrough designation in the US. But if it is a breakthrough device then that would mean the device has to be used in an investigation, right? To test the device safety and effectiveness? But in this case they are only using as if it were already on the shelf and legally marketed.

What's wrong (or not wrong) with this scenario?


Tamiko

Hi Tamiko,
As you said, the device needs an IDE or investigational device exemption to be used in the US if it's not cleared by the FDA. The IDE must be obtained BEFORE the study is initiated. IDE regulation 21 CFR 812 describes 3 types of studies: 1) significant risk (SR); 2) nonsignificant risk (NSR); and exempt studies.  

Significant risk device studies - generally capture implantable devices, those with the potential for serious risk to health or safety, are life-supporting or life-sustaining, or are of substantial importance in diagnosing, curing, mitigating, treating disease, or otherwise preventing impairment.

Nonsignificant risk device studies - those that do not meet the definition of significant risk.

Exempt device studies - typically include all those devices introduced for commercial distribution prior to May 28, 1976, or that the FDA has determined to be substantially equivalent to a cleared device and that is used or investigated in accordance with the indications in the labeling the FDA reviewed in determining substantial equivalence. Also included in this category would be diagnostic devices that are not used to perform invasive testing or sampling procedures that present significant risk. Testing is not used for diagnosis without confirmation. Custom devices, unless used to determine safety and effectiveness for commercial distribution, may also be exempt.

You can find more information on the FDA Guidance Document for IRBs, Clinical Investigators, and Sponsors: https://www.fda.gov/media/75459/download

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Carol
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Original Message:
Sent: 12-May-2023 00:49
From: Tamiko Eto
Subject: Can a CE-marked medical device be used on US patients w/o FDA approval?

A researcher is evaluating an FDA-regulated drug (has IND) for seizures. Part of the assessment is seeing if the drug helps prevent seizures over night (while sleeping). Can they use a CE-marked medical device in the research study to determine if the study drug is working (monitors for seizures) if the CE-marked medical device isn't the actual device under investigation (they're just using it for what it was approved for in the EU, but it doesn't have market clearance in the US)?

My thought is "no". For one: how is it being shipped without an IDE?

The study team says it has a breakthrough designation in the US. But if it is a breakthrough device then that would mean the device has to be used in an investigation, right? To test the device safety and effectiveness? But in this case they are only using as if it were already on the shelf and legally marketed.

What's wrong (or not wrong) with this scenario?


Tamiko