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  • 1.  Selling same device separately as IVD and RUO

    This message was posted by a user wishing to remain anonymous
    Posted 20-Feb-2023 08:22
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Would like to know your insights in this.

    A number of companies seem to be using this pathway but as a manufacturer, can you sell a device labelled as "IVD" within its scope of the intended use but also sell the same device not with the IVD label but with "Research Use Only" label?

    In other words can a same device be labelled and sold separately as IVD and RUO in the same US/EU market?

    Thank you



  • 2.  RE: Selling same device separately as IVD and RUO

    Posted 20-Feb-2023 11:31

    The appropriate strategy for this scenario will ultimately depend on various untold nuances of your case and of the others companies to which you refer.  But in general, once a device is cleared/approved in a particular jurisdiction(s) for its intended use and/or indications for use, then it is required to be labeled in accordance with the cleared/approved labeling when being distributed in said jurisdiction(s) for that cleared/approved intended use and/or indications.

    In contrast, RUO is generally an indication that the RUO is for an uncleared/unapproved intended use and/or indications, or for some other uncleared/unapproved variant.  It is misleading if we label a device as RUO when it is actually being used for its cleared/approved intended use and indications.  That can open the door to regulatory or public health problems.  For example, it can lead to recording of complaints and adverse event information outside of the intended statutory/regulatory channels.  Accordingly, I would stay away from labeling as RUO a cleared/approved device being used for its cleared/approved intended use and/or indications.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: Selling same device separately as IVD and RUO

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2023 08:36
    This message was posted by a user wishing to remain anonymous

    In this situation, the regulatory pathway for the IVD version would have labeling for clinical diagnosis. Whereas the regulatory pathway for the RUO version would have labeling for research use only with the exclusion of any clinical diagnosis use in all of the labeling. Since RUO products are non-regulated (unlike IVD devices that are regulated), RUO products can be marketed with the appropriate intended use/labeling (i.e., no clinical diagnosis use).


    Original Message


  • 4.  RE: Selling same device separately as IVD and RUO

    Posted 21-Feb-2023 08:42

     

     

    I agree with this response.  People may be overlooking the fact that two otherwise identical products that have different labeling are two distinct products.

     

    Certainly the concerns that Kevin listed would still apply, but with two different labels (and presumably product identifiers) it would be possible to manage each product appropriately.

     

    Ted

     

     

     




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  • 5.  RE: Selling same device separately as IVD and RUO

    Posted 21-Feb-2023 09:49
    Edited by Rajeswari Devanathan 21-Feb-2023 10:19

    Hi,

    Labelling with specific intended use, RUO, indications of use and device identifier can be used to differentiate both the IVD and RUO and very good training to marketing and QA processes to ensure the devices are sold only as per the intended use and not off label use.  Have good set QA relase process for the RUO so that device is sold to medical research institutions.  Unless we have some kind of internal control there could be mix ups and confusion and lack of traceability since RUO are kind of open uncontrolled zone. if you can control both device distribution, traceability and post market of the approved device, it is possible sell same device as IVD and RUO. 



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


  • 6.  RE: Selling same device separately as IVD and RUO

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2023 08:46
    This message was posted by a user wishing to remain anonymous

    Thank you everyone for your valuable input.

    It is clear that there is no regulatory restriction per se for labeling the same product as IVD and RUO. Although one needs to bear in mind rigorous QC control, operational and logistic issues, spot on product promotion etc. 


    Original Message


  • 7.  RE: Selling same device separately as IVD and RUO

    Posted 24-Feb-2023 01:28

    I can only imagine the potential for line blurring, particularly amongst the lines between GxP regulatory requirements and those for the RUO product in the quality management system.  If the products are manufactured on the same lines, it will be interesting to see the production and post-production information that may apply directly to the RUO product, but could be omitted for the IVD.  It would be a good thought exercise to map out your QMS to ensure all the lines in the sand are drawn ahead of time and to make sure that the personnel executing to those procedures understand the distinctions. 



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    Christopher Erwin
    Scottsdale AZ
    United States
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    Original Message


  • 8.  RE: Selling same device separately as IVD and RUO

    Posted 24-Feb-2023 13:25

    If an "RUO" device is being investigated for any use and any device configuration that is within the applicable general statutory/legislative scope of medical "device" [e.g., FD&C Act section 201(h); EU MDR Article 2(1), etc., etc.], then the RUO is most certainly NOT, under any circumstance, "non-regulated".

    Only if the "RUO" is outside the scope of the aforesaid applicable general statutory/legislative scope of "medical device" will medical device law/legislation/regulation/ordinances cease to apply.  It is not enough to simply say that the "RUO" is not for "clinical diagnosis".  This is because clinical "diagnosis" is only one of multiple uses that can trigger the statutory/legislative scope of "medical device".  Accordingly, be sure you're applying the full statutory/legislative scope of "medical device" when assessing the device's use in your scenario.

    There are only two pathways for "RUO" of statutory/legislative medical devices:

    1. Use of the cleared/approved device in a post-market trial or other post-market study like an EU MDR PMCF or an FDA post-approval study; and

    2. Use for an uncleared/unapproved use, and/or of a version that is of a significantly different medical device design.

    In RUO scenario 1, the labeling is, by statute and regulation, to be the cleared/approved labeling.  All of the regulatory requirements applicable to the cleared/approved version still apply.  For example, reportable adverse events must still be reported in association with the cleared/approved version, not as some separate RUO version.  Another regulatory requirement is that all GMP obligations still remain.  And others.

    In RUO scenario 2, the RUO is regulated pursuant to applicable regulatory/legislative requirements such as FDA's 21 CFR Part 812 and Europe's MDR Article 62, etc., etc.

    Neither RUO scenario qualifies as being "non-regulated".  Be careful not to step off that cliff.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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