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  • 1.  Indications for Use Strategies

    Posted 05-Feb-2020 15:27
    I work for a medical device company.  I am seeking some suggestions on how to write a good indications for use.  What is a good regulatory strategy for structuring these claims?  What about for the intended use? 

    Thanks.

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    Karen Zhou
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  • 2.  RE: Indications for Use Strategies

    Posted 06-Feb-2020 04:40
    Karen,

    There are a couple other threads on this topic in the RAPS forum if you want to search for them.  There is some disparity around this topic because people view it differently.  For me intended use is a broad statement: 'intended to administer heat to relieve sore muscles.'  Where the indications for use is a more defined statement: 'indications for use is to administer heat to relieve sore muscles in the upper back, lower back, and increase blood flow in these areas.'  If you are looking at the FDA, the indications for use need to be the same as the predicate device, otherwise you have to explain the differences.  The EU MDR complicates it a bit further as they now talk about intended purpose which is even broader than intended use.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Indications for Use Strategies

    Posted 06-Feb-2020 14:43
    For FDA, keep in mind that intended use is general, while indications for use are specific to the disease/condition. Definitions/examples below.

    Intended     Use (this is inclusive of indications for use)

    - The general purpose of the device or its function, including the indications for use
    Example: A diagnostic device to produce images of the heart

    Indications for Use

    - The disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the devices is intended
    Example: A diagnostic device to produce images of the heart to evaluate pulmonary perfusion and function

    As noted in this thread, for FDA, the indications need to the match the predicate device. So look at the claims your predicate device is making, and use that as a starting point for how to structure these. Also, think about how your product testing will be structured, as the regulatory submission and testing will need to be traceable to and directly substantiate the claims you are making in your intended use, indications for use, etc.



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    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
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    Original Message


  • 4.  RE: Indications for Use Strategies

    Posted 07-Feb-2020 09:58
    Except, of course, for the exceptions.

    There are all sorts of "general use" devices for which the official Indications for Use are much broader than the ultimate intended use of the device. In some cases, these "intended uses" of the devices are shown in "examples" in the indications, but not always.

    Think medical lasers, radiation delivery systems, cryoablation tools, surgical meshes, resection loops, surgical robots - the list goes on....

    I echo what other said about starting with the indications of your predicate (if in the 510(k) world) and working from there. If working in the PMA or de novo world, they will ultimately be driven from what your study design is, so it is worth starting with a "perfect wish" indication and then backing up from there based on what can and cannot be reasonably studied.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 5.  RE: Indications for Use Strategies

    Posted 07-Feb-2020 10:17
    Ginger, your advice is always so nuanced - and very helpful. Thanks!

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    Hiral Dutia
    Sr. Regulatory Affairs Specialist
    Third Pole Therapeutics
    Waltham, MA
    USA
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    Original Message


  • 6.  RE: Indications for Use Strategies

    Posted 07-Feb-2020 11:08
    Hi Karen,

    It might help you also to check the below FDA guidance which (although very old) describes the concept of general and specific intended use.
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry
    Also, your strategy should depend on the degree of novelty your device brings to the market. If you have identified already available predicate devices on the market, you may want to check the indications for use of those devices and, depending on the specifications of your devices, shape your own device indications for use. In what concerns FDA, the closer your indications for use will be to your predicate device, the easier will be for you to defend substantial equivalence.

    Kind Regards,

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    Ioana Ulea
    Regulatory Affairs Professional
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    Original Message


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