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  • 1.  Does testing require and IDE

    This message was posted by a user wishing to remain anonymous
    Posted 08-Feb-2021 08:23
    This message was posted by a user wishing to remain anonymous

    My company is developing a new device that patients may wear for weeks.  We are planning to test the wearability performance, ability of the device to stay attached to the patient, by having company employees wear the device and report their experience. Biocompatibility testing has already been successfully completed.

    Does this wearability performance testing constitute a clinical trial?  Do I need an IRB approval to conduct this testing? Is there any guidance from FDA or other regulators that advises when such testing is a clinical trial?

    I expect the results of this testing will be needed in our 510(k) submission.

     Thanks to the group for your advice.



  • 2.  RE: Does testing require and IDE

    Posted 09-Feb-2021 01:50
    Hi Anon,

    Clinical trials are generally not required for 510(k) devices. Have you identified a predicate device? If your wearable device cannot be shown to be as safe and effective as the predicate through appropriate testing, then you may need to do clinical studies (and therefore would need IRB approval). You mention having successfully completed biocompatibility, but have you done other lab tests (e.g. bench performance, design verification)? The testing results will be needed in your 510(k) submission to demonstrate substantial equivalence to your predicate.

    ------------------------------
    Lawrence Maddela
    Regulatory Affairs Specialist
    Irvine CA
    United States
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    Original Message


  • 3.  RE: Does testing require and IDE

    Posted 09-Feb-2021 09:34
    Edited by Melissa Walker 09-Feb-2021 10:33
    What is the difference between an R&D or engineering study done in patients versus a clinical trial that tests the safety and effectiveness of a device (or drug)?  Lots of definitions to be aware of here.  It can be confusing.  

    NIH definition:
    "Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention."  

    Based on that definition, if your study is not for this purpose, it is not a clinical trial in the classic sense.  

    21 CFR Part 56:
    "Clinical investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for purposes of this part."

    Based on this definition, you are conducting a clinical investigation.  It will be included in your submission.  It involves human subjects.  

    As a practical matter, in-house engineering studies are frequently done.  Have seen some with and some without IRB consideration.  Risk offered by the study.  Company policies.  Nature and reason for the study.The classic response? "It depends."    

    Here are a few points for your consideration:
    - Does the study need an IRB review?  The purpose of the IRB review is "to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research." 
    - Recommend that you determine if it meets the definition of a Non-Significant Risk study criteria [see the guidance here https://www.fda.gov/media/75459/download].  Follow the guidance
    - If the study was not using company employees, would you choose/need IRB review?  Strictly speaking, in-house people deserve the same protections as research done using "outside-house" volunteers.  
    - Does the company have relevant policies addressing use of employees for this type of study?

    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
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    Original Message


  • 4.  RE: Does testing require and IDE

    This message was posted by a user wishing to remain anonymous
    Posted 09-Feb-2021 17:30
    This message was posted by a user wishing to remain anonymous

    Melissa,
    Thank you for the detailed response.

    The link you provided fails.  Do you have an updated link to the guidance document?
    Original Message


  • 5.  RE: Does testing require and IDE

    Posted 09-Feb-2021 19:44

    Anon,

     

    Go to the FDA Guidance page - https://www.fda.gov/regulatory-information/search-fda-guidance-documents - and enter "nonsignificant" into the search field.  That should bring it up.

     

    Cheers,

    Melissa

     




    Original Message


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