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How do you search FDA medical device database?

  • 1.  How do you search FDA medical device database?

    Posted 15-Sep-2020 18:58
    Hi all

    Hope you, your family, and loved ones are all safe, healthy, and happy during this tender and trying time.

    We are a team of students from Stanford, Indiana U, and Georgia Tech, we are curious how you search for insight from FDA medical device databases. We prototyped a search engine that mined out all the indications for use and connect the predicates among different devices, we are curious to know if such a search engine will help you in your day-to-day work and what insight/data you are trying to find.

    Thanks!
    Michelle
    danw2@alumni.gsb.stanford.edu


  • 2.  RE: How do you search FDA medical device database?

    Posted 16-Sep-2020 11:09
    Hi Michelle,

    Typically the following FDA site is a good starting for such information. Would be interested to know more about your search engine.

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

    Umang Shah PhD


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    Umang Shah PhD, RAC
    US Head Regulatory CMC Biologics
    Marietta GA
    United States
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  • 3.  RE: How do you search FDA medical device database?

    Posted 25-Sep-2020 01:48
    Dear Umang

    Yes, I use FDA databases and they are great. One thing though is that they don't allow users to search by indications for use. Take "insomnia" as an example, if I use 510k database and search "insomnia" in the device name box, there will be no results, because there is no device with "insomnia" in their brand names. Of course, experienced professionals can find devices via product code and other ways, still it is very convoluted.

    So my team has mined out the data of devices to search by indications, would like to get more feedback.

    Thanks,
    Michelle

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    Michelle Wu
    Palo Alto CA
    United States
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  • 4.  RE: How do you search FDA medical device database?

    Posted 25-Sep-2020 10:00
    While this may be helpful, it's not entirely necessary. The eCFR can be used to easily figure out product codes/regulatory requirements if you can't find what you're looking for in the procode database. You can enter the regulation numbers directly into the FDA's procode database and it will bring up all of the product codes associated with the regulation. Alternatively, you can look at a company's listings on the establishment registration database and derive the procode there.

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    Jeffrey Freedman
    QA/RA Specialist III
    Lowell MA
    United States
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  • 5.  RE: How do you search FDA medical device database?

    Posted 29-Sep-2020 20:45
    Hi Jeffrey

    You are absolutely right. Searching for a product code based on indications to use is not necessary since the FDA product code database is already good enough.

    If my goal is to find a device that has specific indications to use, say, insomnia, then the product code database may not help me to find all relevant devices. Even if I find the specific product code for insomnia, the devices that has insomnia in their indications for use may not use that product code. So my question is that, how critical/useful if you can search by indications to use?What other pinpoints regarding searching for data and insights?

    Thanks,
    Michelle

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    Michelle Wu
    Palo Alto CA
    United States
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  • 6.  RE: How do you search FDA medical device database?

    Posted 28-Sep-2020 07:54

    Hello – if there is a predicate, find the product code and then search by product code to find previously cleared products.

     

    _________________________________________________

     

    Diane Uriell

    Sr. Director, Global Regulatory Affairs Women's Health and Xray

    GE Healthcare

     

    T +1 262-290-8212

     

     






  • 7.  RE: How do you search FDA medical device database?

    Posted 29-Sep-2020 20:50
    Dear Diane

    Good suggestion. Can I ask how often will people already have a predicate in mind and find the product code then search for the devices? I want to understand, say, xyz% of users already know which predicates to use v.s.  % of users not sure and want to search for a predicates, if the number of users searching for predicates is significant, then how much time/efforts does it take to find a predicate?

    Thanks,
    Michelle

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    Michelle Wu
    Palo Alto CA
    United States
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  • 8.  RE: How do you search FDA medical device database?

    Posted 28-Sep-2020 09:46
    Hi Michelle,

    If you download the file from ​"Download Product Code Classification Files" run a search on key word such as insomnia you will be able to identify the product code for further details. In any case would like to test your search engine if the bot is able to perform a wider search with multiple hits vs having to search sequentially especially connecting predicates in a single search once you input as you suggested "insomnia" as search criteria..

    https://www.fda.gov/medical-devices/classify-your-medical-device/download-product-code-classification-files#file

    It contains 18 elements and "indication" is one of them.

    Thanks,

    Umang Shah PhD MBA RAC
    US Head, Regulatory Affairs

    ------------------------------
    Umang Shah PhD, RAC
    US Head Regulatory CMC Biologics
    Marietta GA
    United States
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  • 9.  RE: How do you search FDA medical device database?

    Posted 29-Sep-2020 20:32
    Dear Umang

    Great suggestion! I did the following based on your instruction:
    1. download the Product Code foiclass.zip from the link
    2. use the key word "insomnia"
    3. find 2 product code "PLU" and "QJQ"
    4. Go to FDA 510k, PMA, De Novo databases to search by the two product code.
    There is no device cleared under QJQ and only 1 device un PLU, DEN140032.
    The whole process takes me about 2-5min ish to follow your link, download the file, then use "key word" search.

    However, if I use my search engine and search by devices' indications to use, using the same keyword "insomnia", there are 8 devices that has mentioned "insomnia" :
    6 under JXK: K024377, K060158, K062284, K070412, K090052, K182311
    1 under PLU: DEN140032
    1 under LQD: K141865

    So my follow-up questions, if my goal is to find a device treating certain disease or have certain features, e.g. stainless steel vs. titanium alloy; how can I make the search that exhaust all possible devices? When people search for a device to find out if this device will be their ideal predicates, they normally start off with product code? How satisfying to use product code to search for devices vs. alternatives if enabled by technology? How often do people search FDA databases and how much time do people normally spend on FDA databases?

    Thanks,
    Michelle




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    Michelle Wu
    Palo Alto CA
    United States
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  • 10.  RE: How do you search FDA medical device database?

    Posted 29-Sep-2020 20:43
    Hi Michelle,

    This means a couple of things. Perhaps the file is not updated or the keyword search leading to pdt code followed by searching the databases does not perform a comprehensive search.... Or something is else is amiss in terms of additional key words.

    I would like to view your search engine as you conduct the search via zoom as it certainly appears to have benefits.​

    Umang

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    Umang Shah PhD, RAC
    US Head Regulatory CMC Biologics
    Marietta GA
    United States
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  • 11.  RE: How do you search FDA medical device database?

    Posted 29-Sep-2020 20:52
    Awesome! Happy to demo and hear feedback from experts like you:)

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    Michelle Wu
    Palo Alto CA
    United States
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  • 12.  RE: How do you search FDA medical device database?

    Posted 30-Oct-2020 02:39
    Edited by Divy Amin 30-Oct-2020 02:40
    Hi Michelle,

    Your approach is very exciting. I am really curious to see your database demo. 


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    Divy Amin
    Principal, Regulatory Affairs
    Ann Arbor, MI
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