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  • 1.  Intended Use - key elements

    This message was posted by a user wishing to remain anonymous
    Posted 18-Oct-2022 09:39
    This message was posted by a user wishing to remain anonymous

    What are the key elements to be considered in a device's intended use statement? 
    ( Let's say you are about to write an intended use statement from scratch what is your checklist)
    Thanks,


  • 2.  RE: Intended Use - key elements

    Posted 19-Oct-2022 01:13
    Hello Anon,

    This is a difficult question to answer because there are so many factors which contribute to intended use.  Also keep in mind there can be differences between intended use and indications for use depending on which regulatory market you are speaking about.  The intended use statement can be more broad, so the elements would be device type, what it does, and the disease condition.  The indications for use is more specific, so the elements could be device type, what is does, how it does it, disease condition, population, anatomical location, outcome.  Just as examples.  A good idea is to look at various 510(k) Summary from the US FDA database as there are many, many examples of indications for use (and intended use) to get an idea.  Plus depending on the market you are addressing, unless your product is completely new and novel, usually the intended use/indications for use statement is going to be quite similar to the predicate device (US FDA) or similar devices on the market (other regulatory jurisdictions).

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


  • 3.  RE: Intended Use - key elements

    Posted 19-Oct-2022 08:22
    Agree with Richard.  There have been various guidance documents about "intended use" and "indications for use".  They can have the exact same wording, or be different.  You can check out the labeling guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/device-labeling-guidance-g91-1-blue-book-memo) for a definition of "indications for use".  Some descriptions and definitions there that might help you.

    After you take a look at that guidance, follow Richard's recommendation and review the IFU/Intended Use statements in recent summaries.  Focus on your particular type of device to get an idea of how FDA is applying these definitions now.  Interpretation and requirements can change over time.

    Cheers,
    Melissa

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


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