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  • 1.  Research Use Only

    Posted 31-Aug-2015 07:49

    The IVD regulation references use of the terminology “Research Use Only”.

    What are experiences with applying this terminology and labeling to non-IVD devices, such as active medical devices performing a biopotential data acquisition function when attached to a subject, but not intended for clinical monitoring of the subject, intended for use in research only?


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    Gary Syring RAC
    United States
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  • 2.  RE: Research Use Only

    Posted 01-Sep-2015 09:57

    If the device is an active medical device, (and it is not an IVD) are you using it under its current intended use? If so there is no need to relabel it because you are using it as it is intended. If the device has a very specific intended use that you are not compliant to, then what is the new intended use? Using a device that outside of its intended use on a human would require investigational use labeling under 812.5 and be subject to the clinical regulations (IRB, etc). Looking at the CFR, there does not appear to be the clear labeling rules for RUO on devices as there are for IVD.

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    Sarah Parsons RAC
    Director Regulatory Affairs
    Janssen Diagnostics
    Pittsford NY
    United States
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    Original Message


  • 3.  RE: Research Use Only

    Posted 02-Sep-2015 09:34

    I can shed some light as I have been involved in a previous life with very similar studies. As mentioned, there are no clear instructions for RUO for devices as there are for IVDs, so any study outside the cleared intended use would need to follow the Investigational Device Exemption (IDE) and clinical regulations. However, if the study design is limited to data collection and observation only without affecting clinical decision making (as you state, not used for clinical monitoring), then you can make your case that the study is observational only and poses a Non-significant risk to the Institutional Review Board. If the Board agrees and approves the study, you will not need to get an IDE from FDA for this study. The IRB will likely ask your device to be examined by clinical engineering in the hospital to ensure the device does not pose a safety risk to the patient (typically they do leakage current testing, etc). The device will need to follow labeling requirements for investigational devices and be very clear that it should not be used for clinical monitoring.

    Hope this helps!



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    Manan Hathi RAC
    Regulatory Affairs Specialist
    Stryker Communications
    Flower Mound TX
    United States
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    Original Message


  • 4.  RE: Research Use Only

    Posted 02-Sep-2015 16:19

    Good afternoon,

    The problem to be considered is: "Is the device approved/cleared by the FDA?". If this is not a FDA approved/cleared device,  in order to be legally shipped  to the USA and through state lines, it should have the RUO label, independently if it is for an animal or clinical study. As already presented by others, this is independent from IRB approved protocol and/or an IDE with the FDA. If the device is already approved for use in the USA, the ROU is not required (*IRB and IDE may be*).



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    Valeria Sena-Weltin RAC
    Sr. Regulatory Affairs Associate
    New Market MD
    United States
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    Original Message


  • 5.  RE: Research Use Only

    Posted 03-Sep-2015 11:51
    Gary,

    "active medical devices performing a biopotential data acquisition function when attached to a subject, but not intended for clinical monitoring of the subject..."

    Your above-statements invoke the following regulations based on 1). a medical device; 2). a human subject; 3). for investigational use or for research use.

    21 CFR Part 812
    21 CFR Part 56 AND/OR 45 CFR Part 46, etc.

    As for general devices, it is about whether it is a significant risk (SR) device or non-SR.

    If it is a non-SR, an IRB approval is required.

    When involving a human subject with a medical device, it is subject to 21 CFR Part 56 and/or 45 CFR Part 46 under your situated circumstances. 

    You may refer to the following:

    FDA Regulations for Good Clinical Practices at <http://fdaguidance.net/fda-regulations-for-good-clinical-practices/> 


    IRBs Explained Per 21 CFR Part 56 and 45 CFR Part 46 <http://passfda.com/irbs-explained-per-21-cfr-part-56-45-cfr-part-46/> 

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


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    Original Message


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