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  • 1.  Clinical Data Requirements for Class II devices in U.S

    Posted 08-Feb-2022 09:30
    Dear All,

    I really appreciate the responses i get whenever i write for any query.

    Question: how do we know if our product require clinical data and what tests or investigation have to be included in the clinical data, i could not find a direct information or a guidance mentioning something like that.

    I wish to to have a positive feedback on the question.

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    Rabel Talpur
    Freiburg
    Germany
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  • 2.  RE: Clinical Data Requirements for Class II devices in U.S

    Posted 09-Feb-2022 10:21
    Hello Rabel

    It depends on the type of device. Most devices in class II will require a 510(k) pre-market notification, and some 510(k) submissions will require clinical data. You can find an overview here:

    https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device

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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: Clinical Data Requirements for Class II devices in U.S

    Posted 09-Feb-2022 10:34
    Dear Anne,

    Thanks for your reply, so our product group comes under the HBL (product Code Category), and as i understood that each device group code mentions the guidance and Recognized consesus standard that have to be followed and tests need to be done accordingly to support the SE with predicate, the main point is i can not find the exact meaning or definination of clinical study ( do the devices which are in contact with blood require clinical study as our product are class two and not in direct or in indirect contact to patient body fluids.

    so what i have understood as per the Knowledge i have that we can provide Clinical study for devices such as:
    1: IDE Device category
    2: IVD and device which are in direct contact to blood 
    3: Devices which have to comply with ISO 14155 Standard

    How would you define Clinical study and when it is required for what kind of devices in your point of view?

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    Rabel Talpur
    Freiburg
    Germany
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    Original Message


  • 4.  RE: Clinical Data Requirements for Class II devices in U.S

    Posted 09-Feb-2022 14:37
    Yes, 510(k) is appropriate for devices in code HBL.

    Clinical study or clinical investigation is defined as research involving one or more subjects to determine the safety or effectiveness of a device. (21 CFR 812.3)

    You can find some information about when such studies are needed and how to get them approved here:
    https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/investigational-device-exemption-ide

    Most 510(k) submissions don't need clinical studies. I think it will depend on how different your device is from its predicate.

    You can find some discussion here about the reasons a 510(k) reviewer would expect to see various kinds of supporting performance data, both non-clinical and (sometimes) clinical:
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-equivalence-premarket-notifications-510k

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    Anne LeBlanc
    United States
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    Original Message


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