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  • 1.  General/Specific Intended Use

    Posted 09-Mar-2020 16:13
    Greetings,
    Anyone have any experience related to the "General/Specific Intended Use" Guidance (1998) to aid in determining substantial equivalence? Specifically, I am stuck on the following:

    "… Specific indications for use that ordinarily fall outside a general use for the purpose of determining substantial equivalence include…

    • those indications for use that involve the diagnosis, therapy, or prevention of a particular disease entity or entities, especially where such entity carries clinical implications not normally associated with other general uses of the device."

    How does someone determine the "disease entity or entities"? I am assuming this is the specific intended/indicate patient population... but curious how specific/detailed it needs to get? The whole "entity" thing is throwing me off as I can't seem to find a solid definition of this in FDA and CFR land. 

    What is meant by "entity carries clinical implications not normally associated with other general uses of the device"? Anyone have a good a example outside of what is presented in the guidance?

    Thank you!

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    Danielle Briggeman MS
    Clinical & Regulatory Affairs Manager
    Portland ME
    United States
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  • 2.  RE: General/Specific Intended Use

    Posted 10-Mar-2020 09:21
    Danielle,

    There are a couple other threads on this subject, if you do a little searching there is some other information.

    If you are talking about the 510(k) Premarket Notification process, the intended use/indications for use statement must be the same as the predicate device.  If there are any differences in the intended use/indications for use statement, then the company must provide rationale and/or justification for the difference.  This could be done through either non-clinical or clinical testing.  The challenge some companies face is using a predicate device >10 years old because the US FDA is much more stringent on these statements now.  (There are other regulatory agencies like Canada, EU, Japan that are becoming or are also just as stringent.)

    From my perspective a General Intended Use = Intended Use.  A Specific Intended Use = Indications for Use.

    To give an easy example.  An intended use: The thermal pack is intended to provide heat for relief of sore muscles.  An indications for use: The thermal pack is intended to provide relief of sore muscles and increased blood flow in the neck, upper back, and shoulders for temporary relief of pain.

    Included in the thought process is the indications for use would be specific anatomy, specific population, conditions of use, or even specific operating parameters of a device.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: General/Specific Intended Use

    Posted 11-Mar-2020 07:05
    Danielle,

    I heartily endorse Richard's description of the difference in Intended Use and Indications for Use.  In fact, in our procedure I have defined as the following:
    Intended Use (a general statement of the customary use of the device intended by the manufacturer).
    Indications for Use (a specific statement of what the device does and use population, e.g. age, sex, professional or lay user).

    In my discussions with FDA, this seems to be what they are looking for.

    Regards,
    James


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    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
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    Original Message


  • 4.  RE: General/Specific Intended Use

    Posted 11-Mar-2020 11:06
    Thank you, James and Richard. I appreciate you taking the time to provide feedback! I have an understanding of intended use and indications use, but the way the guidance (in the particular example I provided) uses "disease entity or entities" is what is confusing for me. Is this essentially the patient population no matter how specific, e.g., this could be the diagnosed disorder + age restriction + symptom/presentation restriction, etc.?

    ------------------------------
    Danielle Briggeman MS
    Clinical & Regulatory Affairs Manager
    Portland ME
    United States
    ------------------------------

    Original Message


  • 5.  RE: General/Specific Intended Use

    Posted 11-Mar-2020 20:48
    Maybe I can offer a better example.
    One of the product types I've dealt with and had many interactions with the FDA are Computerized Cognitive Assessment Aid (codes PKQ and PTY). FDA considers these types of products to have general indications, sometimes also referred to as "tool".
    A similar product, but with specific indications is a "Computerized Cognitive Assessment Aid for Concussion" (code POM). FDA determined that is a cognitive tests used as an aid for concussion assessment have a different intended use than the general cognitive assessment aid (requiring a DeNovo).

    Another version of the cognitive test could be for dementia, or Alzheimer's, or other diseases or conditions that affect cognition.

    So the disease entity would be the specific condition for which a manufacturer would promote the product, such as concussion or dementia from the examples above.

    You've probably already read the General vs Specific guidance, but I would also recommend the article by DuVal & Associates
    http://www.duvalfdalaw.com/news/client-alerts/clearing-your-indications-for-use-staying-under-the-umbrella-of-intended-use

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    Michael Zagorski RAC
    Director of Regulatory Affairs
    Pittsburgh PA
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    Original Message


  • 6.  RE: General/Specific Intended Use

    Posted 12-Mar-2020 10:21
    "Disease entity" is what it says - not generally further details of a patient population (which by the heirarchy FDA calls out in the guidance, would fall at a "next more specific level" than "disease entity." I know though that the guidance doesn't call this out, but it fits with their thinking.

    General use: "cuts tissue using RF"
    Location (more specific) "cuts brain tissue using RF"
    Disease entity (more specific) "removes brain tumors"
    Further specificity: "removes brain tumors in patients with KPS score of 60 or more"
    Very specific: "removes brain tumors in patients with KPS score of 60 or more with an average of 6 months additional overall survival"

    I kind of view it as the guidance describes a concept.  There are a lot of nuances for specific products/indications that fall between the tiers they describe but if you stick with the "hierarchy" construct you can usually figure out how to slot them in appropriately.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 7.  RE: General/Specific Intended Use

    Posted 12-Mar-2020 10:59
    Thank you tremendously, Ginger and Michael! This is exactly what I needed!

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    Danielle Briggeman MS
    Clinical & Regulatory Affairs Manager
    Portland ME
    United States
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    Original Message


  • 8.  RE: General/Specific Intended Use

    Posted 12-Mar-2020 09:46
    Edited by Andrea Chamblee 12-Mar-2020 09:46
    Intended Use includes statements and implications on the label. If your intended use on the label is for hand-washing, but your links and accompanying materials say it cures the coronovirus, your indications for use includes curing the coronovirus.

    Don't ask me how I came up with that example. 

    😊


    "Intended use is one of the most commonly used phrases, yet it's so often misunderstood. It is not what your device is designed to be used for or even what it could be used for. It's about what your label claims--what you say your device is meant to do."
    "    Indications for use cover the reasons or situations in which someone would use the device. Under what conditions will the product be used? This is a term that is also commonly used in other areas, such as for classifying drugs and medications"
    https://www.mddionline.com/why-you-must-know-difference-between-intended-use-and-indications-use

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    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
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    Original Message


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