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  • 1.  LDTs using FDA-cleared IVDs

    Posted 16-Mar-2022 06:47
    Edited by Shailesh Joshi 16-Mar-2022 06:57
    Hi All,

    There is a view that clinical laboratories in US are compelled to use FDA cleared products i.e. IVDs (where they are available) in their LDTs  as opposed to RUOs. 


    Is this true? and if it is then has this been explicitly written by FDA or CMS?

    Thank you

    Shailesh



  • 2.  RE: LDTs using FDA-cleared IVDs

    Posted 17-Mar-2022 05:56
    Hello Shailesh,

    There is a lot of underlying information about this - to answer your question: no there has been nothing explicitly written down for LDT/cleared device usage.  In fact, a few years ago FDA was promising LDTs would be regulated, there was a draft guidance put out, withdrawn, as there was so much controversy around this subject.  There is a lot of history.  There is still a lot of discussions around this point.  Too much to just write in a forum post.  Just a final note, there is a difference between LDT and RUO - RUOs are research use only, so they should only be used for research meaning not reporting out patient results to patients.

    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: LDTs using FDA-cleared IVDs

    Posted 17-Mar-2022 06:12
    Hi Richard,

    Thank you for your response and answering my question. 

    LDT manufacturers (such as a clinical lab) though can use RUO products from other manufacturers and create their own LDTs.

    On further research I found this blog which might be helpful to others:

    https://blog.dnagenotek.com/do-you-need-an-fda-cleared-dna-collection-device-for-your-laboratory-developed-genetic-test-ldt

    Shailesh



    ------------------------------
    Shailesh Joshi
    Regulatory Manager
    Guildford
    United Kingdom
    ------------------------------

    Original Message


  • 4.  RE: LDTs using FDA-cleared IVDs

    Posted 18-Mar-2022 12:52
    Hi Shailesh,

    Yes, you and are Richard are both correct. RUO's can be used to develop an LDT but to Richard's point, you cannot take an RUO, follow the IFU's exactly and call it an LDT. You can use the RUO to make an LDT.

    Something to keep an eye on is new legislation being developed called the VALID Act. This will place IVD manufacturers and clinical laboratories developing LDT's under the FDA's jurisdiction and they would be referred to IVCTs (InVitro Clinical Tests). As Richard mentioned, there has been a lot of controversy regarding LDTs and there is a lot of grey area due to FDA's claim of enforcement discretion.

    Julie

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    Julie Rees
    Regulatory Coordinator
    Rochester MN
    United States
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    Original Message


  • 5.  RE: LDTs using FDA-cleared IVDs

    Posted 21-Mar-2022 06:25
    Hi Julie,

    Thank you for sharing this information. Aware of VALID act but and also agree there is been a lot grey area when it comes to LDTs.

    Regards

    ------------------------------
    Shailesh Joshi
    Regulatory Manager
    Guildford
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: LDTs using FDA-cleared IVDs

    Posted 17-Mar-2022 07:08
    No, this is not true. However, if you are using an IVD as part of a clinical trial enrollment criteria, and a cleared/approved device is available, FDA will step fly suggest it be used and may require an IDE depending on the study risk.

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    Sarah Parsons RAC
    Director Regulatory Affairs, Diagnostics
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    Original Message


  • 7.  RE: LDTs using FDA-cleared IVDs

    Posted 21-Mar-2022 06:29
    Hi Sarah,

    Thank you for your input on this question. Is this something similar to IVDR clause which requires Healthcare institutions manufacturing LDTs to provide a "Justification" that there is no suitable IVD in the market to meet the unmet need?

    Regards,

    ------------------------------
    Shailesh Joshi
    Regulatory Manager
    Guildford
    United Kingdom
    ------------------------------

    Original Message


  • 8.  RE: LDTs using FDA-cleared IVDs

    Posted 21-Mar-2022 06:39
    You could make that analogy, but the IVDR is regulation, and what I mentioned in the last post (forgive my typo, I meant to say 'strongly suggest') is my experience, and not documented in law or guidance. I am happy to discuss further if you wish.

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    Sarah Parsons RAC
    Director Regulatory Affairs, Diagnostics
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    Original Message


  • 9.  RE: LDTs using FDA-cleared IVDs

    Posted 21-Mar-2022 06:47
    Thank you Sarah for sharing your comments. Guess it's fair to say it comes down to the risk....
    I agree totally that experience in this field will teach a lot on how FDA thinks.

    Regards,

    ------------------------------
    Shailesh Joshi
    Regulatory Manager
    Guildford
    United Kingdom
    ------------------------------

    Original Message


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