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  • 1.  Laboratory Developed Tests for IDE Submission

    Posted 20-Jun-2023 17:36
    Edited by Joscelyn Bowersock 22-Jun-2023 16:19

    REDACTED



  • 2.  RE: Laboratory Developed Tests for IDE Submission

    Posted 21-Jun-2023 05:16

    Hello Joscelyn,

    Nice to see you.  I am not sure following along the question completely, but submitting an IDE depends on whether the LDT would be considered non-significant risk or significant risk.  This of course depends on if a planned submission is being made and the information under the IDE is being used for subsequent submission.  If the IVD is going to only be sold as a Laboratory Developed Test (LDT) then CLIA might be applicable.  This is usually more a laboratory focused requirements and depends on how the test is going to be used.  You can reach out to me if you need to discuss further.



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


  • 3.  RE: Laboratory Developed Tests for IDE Submission

    Posted 21-Jun-2023 05:58

    The accepting laboratory  (CLIA lab) needs to understand and follow acceptable design transfer and the IDE sponsor (filing party) must assure adequate validation of the test to support the IDEs intended purpose. My experience with EU labs is that their own validation runs short of FDA validation expectations so someone experienced in US requirements should work with both labs to assure the validation provided in the IDE is adequate.  



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    Sarah Parsons RAC
    IVD Regulatory Affairs
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    Original Message


  • 4.  RE: Laboratory Developed Tests for IDE Submission

    Posted 21-Jun-2023 11:15

    This is an area that can be confusing.

    First, it is not clear if your company's role is to run the test on patient samples (a lab) or to manufacture the test (IVD manufacturer) for use in a lab. Also, is it a lab in your company, a lab in another company, or both.

    I'll infer your company is the manufacturer. First, start with 812.2(c)(3) to determine if your IVD is exempt from the IDE regulations. This will take you to 809.10(c).

    If the IVD is not exempt, then you will need to file an IDE following 812.

    If the IVD is exempt, determine if your project is in either the RUO phase or the IUO phase of development.

    In either case, determine whether the IVD is Class I. If so, design controls under 820 do apply.

    Based on the description, your IVD cannot be an LDT, because it is transferred from another site. It won't pass the "four walls" test, which means an LDT must be developed and run in the same lab. Transfer is not allowed. Consequently, the CLIA requirements for developing an LDT in a high-complexity lab do not apply.

    As an aside, FDA will announce its plans to regulate LDTs in August this year.



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


  • 5.  RE: Laboratory Developed Tests for IDE Submission

    Posted 21-Jun-2023 15:22
    Edited by Joscelyn Bowersock 22-Jun-2023 16:20

    REDACTED



  • 6.  RE: Laboratory Developed Tests for IDE Submission

    Posted 21-Jun-2023 17:25

    I was wondering.

    You raised this as an LDT with the expectation that it fall under the CLIA rules for an LDT, which requires a high-complexity lab.

    This won't qualify as an LDT in the US because of FDA regulations. An LDT in the US must be developed in the same CLIA high-complexity lab in which the test is run. It cannot be transferred from another lab (even labs owned by the same company). This is the "four walls" test. The LDT development and the test must be run inside the same lab. You cannot transfer a test from another lab and run it as an LDT.

    Historically, FDA's position is that LDTs are IVD medical devices which FDA regulates. However, FDA decided to exercise enforcement discretion on LDTs. At that time, a hospital may develop a test specific to a patient. FDA did not see value in regulating these tests. Since then, LDTs have grown in scope including large labs such Quest and direct-to-consumer tests such as 23-and-Me. FDA intends to regulate them, and in August will announce its plans.

    This test will, likely, require a submission to FDA. The first step is to determine the device class. A Class I device will probably not require a submission.

    If it is a Class II or Class III you will need a premarket submission to FDA.



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


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