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  • 1.  Registration Requirements for Laboratory Developed Tests

    Posted 04-Apr-2022 16:08
    Hello,

    I've been trying to put together registration requirements and timelines for an IVD. The assay is run here in the US but test is to be offered in a number of countries. The collection kits are being registered separately. My understanding is in the US, these are referred to as laboratory developed test (LDTs) where all the tests are run at one location.

    My question is whether these are regulated or registration required OUS? I am hearing from other regulatory leads in my company that registration is not required for the assay, only for the collection kit in Australia and Canada. Is there a resource I can use to find information on Japan, Singapore, Brazil, Mexico, and EU?

    Update: My understanding is under IVDR, these fall under distance sale provision and are covered by IVDR

    Thanks!

    J

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    J. Fox JD
    Senior Regulatory Specialist
    Arvada CO
    United States
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  • 2.  RE: Registration Requirements for Laboratory Developed Tests

    Posted 05-Apr-2022 04:24
    Hello J,

    The information you are seeking can be quite varied between all those countries and products which are IVD laboratory tests, kits, reagents, or materials can make the regulatory pathway even more complicated.  In some of these countries there is no specific regulations concerning laboratory tests so there is much interpretation around what is the type of test, the assay marker, or the disease condition the test is determining.  And there is no such thing as LDT under IVDR - there are just IVD medical devices ... and yes distance sales provisions do apply depending on central lab type of testing.  You might want to seek some expert advice in those countries to understand the regulatory requirements around these products.

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


  • 3.  RE: Registration Requirements for Laboratory Developed Tests

    Posted 05-Apr-2022 09:18

    For the US, you need to be careful about LDTs. The US FDA regulates the tests and CMS, through CLIA, regulates the lab that conducts the tests.

    For many LDTs FDA uses enforcement discretion in which they don't regulate the tests. However, FDA does regulate direct to consumer, DTC, testing and requires a pre-market submission. There is an interesting Warning Letter to 23 and Me that forced them to take all of their medical tests of the market until they received clearance or approval. They did continue to market the tests for ethnicity determination. For CMS, the lab must be a high complexity lab to run the LDTs.

    For the EU, the IVDR says that only hospitals can offer LDTs. It is not clear to me that the regulation allows specimen collection in the EU and then shipment to the US for testing. In addition, Article 6 on Distance Sales says the device must meet the IVDR and the Competent Authority can request the DoC.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 4.  RE: Registration Requirements for Laboratory Developed Tests

    Posted 05-Apr-2022 11:36
    I think the prior comments cover most of the basics. The only other thing I would add is that the IVDD is much more lax about IVDs in Europe than the IVDR so you may be able to "self cert" before the IVDR comes into full force. Also, every country around the world is different so you need to do some research. In Japan for example, you can do distribute the product pretty easily if it is paid by the patient rather than reimbursed by the national health service. For the US my rule of thumb for LDTs was no "direct to consumer" and no "pharmacogenomics". Those are the two areas I know where FDA has elected to apply enforcement. Otherwise just make sure you have a CLIA license for high complexity testing as already mentioned. Also think about your sample collection process and whether you are using an approved/cleared kit or if you are making a custom one in house for distribution.

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    Lucas Fernandez
    Director, Medical Devices Compliance
    Broomfield CO
    United States
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    Original Message


  • 5.  RE: Registration Requirements for Laboratory Developed Tests

    Posted 05-Apr-2022 17:41
    Edited by Christie Hughes 05-Apr-2022 17:41
    Hi J,

    Yes, for Europe (EU + EEA countries), the test provided by a reference laboratory is treated the same under the IVDR as a test kit provided by an IVD kit manufacturer. You would need to follow the same regulatory pathway as a manufacturer to conduct performance evaluation and draw up technical documentation, including a declaration of conformity, to demonstrate conformity with IVDR requirements. Depending on device classification under the IVDR, you would also need to engage with a Notified Body designated for IVDs (and your specific type of test(s)) or with an authorized representative to complete the conformity assessment and/or registration process.

    Keep in mind that depending on what devices your collection kit includes, these may be regulated under MDR and not IVDR. Pay attention to definitions and available MDCG guidance for qualification of products as devices and device classification for both MDR and IVDR. The same applies for any software that your lab may offer for delivering test results to clinicians or patients as there are specific MDCG guidance available for software as a medical device and that used for in vitro diagnostics.

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    Christie Hughes MT(ASCP), MPH
    Principal Consultant
    Austin, TX
    United States
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    Original Message


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