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  • 1.  Monitoring FDA Databases for Market Withdrawal

    Posted 17-Feb-2023 11:50

    Greetings,

    I'm interested in monitoring FDA databases (preferably automated) for instances of Market Withdrawal of a competitor's device(s). Is anyone aware of a method/service to do this and what would be the best database to watch (MAUDE, TPLC)?



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    Michael Thomas
    Director Regulatory Affairs
    Salt Lake City UT
    United States
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  • 2.  RE: Monitoring FDA Databases for Market Withdrawal

    Posted 17-Feb-2023 12:48

    In Part 806, market withdrawal means a correction or removal of a distributed device that involves a minor violation of the act that would not be subject to legal action by FDA or that involves no violation of the act, e.g., normal stock rotation practices.

    This kind of market withdrawal is a reporting exception under Part 806, so FDA would not know when it happens.

    I suspect, however, this is not your question. I think you are asking how to know if a competitor no longer offers a device.

    I can think of two ways.

    The manufacturer needs to register and list. If the device is no longer made available, then it should come off the listing. Since the data only shows what is on the list, you would need to make periodic comparisons.

    If the device is not available, the manufacturer should update GUDID which will show up in AccessGUDID. Again, periodic checking seems to be the method.

    Neither TPLC nor any of its feeder databases have this information.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: Monitoring FDA Databases for Market Withdrawal

    Posted 18-Feb-2023 13:13

    Basil systems ?



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    Joy Frestedt PHD, CPI, RAC, FRAPS, FACRP
    President and CEO
    Frestedt Incorporated (www.frestedt.com)
    Saint Louis Park MN
    United States
    612-219-9982
    jf@frestedt.com
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    Original Message


  • 4.  RE: Monitoring FDA Databases for Market Withdrawal

    Posted 20-Feb-2023 19:10

    Michael,

    Basil Systems does have the entire GUDID database integrated into our RA/QA platform.  So for example you can easily and quickly scan UDI records within a product code or for a particular company/brand and immediately see if their commercial distribution has been ended.   Let me know if you want more info (ross@basilsys.com).

    Here's a sample screen shot:

    Cheers,

    Ross



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    Ross Meisner
    Chief Commercial Officer
    Boston MA
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    Original Message


  • 5.  RE: Monitoring FDA Databases for Market Withdrawal

    Posted 20-Feb-2023 10:41

    Dear Michael

    I am happy to speak with you. Vivpro has changed the regulatory intelligence landscape from database (most current platforms) to contextual intelligence delivered through machine learning. We currently have 1.6M documents (and growing) that allow playing every drug/biologic like a movie and effectively extract intelligence with natural language query. 

    We monitor 200k+ devices as well.

    Currently, Vivpro R&D intelligence Assistant (RIA) is licensed by 20+ pharma/biotech companies including FDA.

    My contact information is below if you are interested. Looking forward to speaking with you.

    Pravin Jadhav
    CEO Vivpro
    pravin@vivpro.ai
    https://vivpro.ai



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    Pravin Jadhav
    CEO
    Lansdale PA
    United States
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    Original Message


  • 6.  RE: Monitoring FDA Databases for Market Withdrawal

    This message was posted by a user wishing to remain anonymous
    Posted 23-Feb-2023 08:46
    This message was posted by a user wishing to remain anonymous

    Even though this is not an automated method and is manual to monitor but is free, subscribing to FDA's CDRH New email alerts provides devices that have been revoked, terminated or withdrawn by viewing the revocation letter and updated IFU. Per CDRH New's description, this is "a daily digest of the previous business-day's new additions and updates to CDRH's webpages." CDRH New entails of the marketing status for EUA devices, as well as infusion pumps, IVDs, personal protective equipment, and decontamination systems for personal protective equipment. There are also CDER New email notifications you can subscribe for.


    Original Message


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