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Does a change in Intended Use to previous IVD 510(k) submission

  • 1.  Does a change in Intended Use to previous IVD 510(k) submission

    Posted 08-Mar-2017 10:02
    If an IVD's intended use changes only in the setting in which the tests will be performed to "point of care" will that require a new traditional 510(k)?  To explain:  The IVD instrument itself has not been changed in any way, but instead of the testing being performed in a hospital lab setting, it will be performed by professionals in a remote lab facility or a remote health care facility.  The indication for use will change to a new assay from the pervious 510(k) which will require a "modified" 510(k) submission.

    If a new traditional 510(K) is required, should the name of the IVD instrument from the previous 510(k) submission change to indicate it is point of care.  Also, can the IVD instrument from the previous 510(k) submission be used as the predicate device.

    Thank you!

    Noemi

    ------------------------------
    Noemi Olivo
    Milford CT
    United States
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  • 2.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 06:21
    Hello Noemi,
    I believe a new 510(k) is required for addition of point of care settings in the intended use.
    You may use the current cleared device as the predicate. Please see the example in the link.
    http://www.accessdata.fda.gov/cdrh_docs/reviews/K062924.pdf

    ------------------------------
    Wan-Li Liao
    Regulatory Affairs Specialist
    Philips
    Netherlands

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    Original Message


  • 3.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 13:39
    Thank you all for your expert and timely advise!!

    ------------------------------
    Noemi Olivo
    Milford CT
    United States
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    Original Message


  • 4.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 06:23
    Hi Noemi,

    Any change in indication for use will require a new traditional 510(k).  You may use the existing instrument/test as the predicate, but you should also have a predicate that has point of care use if possible.  A change in name is not required for regulatory purposes, but may be desired from a marketing perspective.

    Regards,
    James




    Original Message


  • 5.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 13:41
    Excellent advice.  We will more than likely add POC to the existing title of the device.  Thank you!

    ------------------------------
    Noemi Olivo
    Milford CT
    United States
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    Original Message


  • 6.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 14:00
    Hmmm...if you need to add a second predicate for POC, because the existing device isn't POC, might FDA consider that a split predicate?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 7.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 10-Mar-2017 07:09

    Julie,

     

    This would be a situation of a multiple predicate, rather than a split predicate.  FDA considers a split predicate when one uses an indication from one device and a technology from a second device.  I did not perceive that to be the case here.  Additionally, the POC predicate is optional.  FDA would not necessarily require such for a simple expansion in the use setting.  I successfully obtained clearance for a 510(k) where we expanded the setting from a hospital /clinical use device to an ambulatory use by incorporating data which demonstrated the robustness of the device while being bounced around and subjected to electrical and radio interference.

     

    Regards,

    James



    ------------------------------
    James Bonds
    Director Regulatory Affairs
    Woodstock GA
    United States
    ------------------------------

    Original Message


  • 8.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 10-Mar-2017 10:42
    Hi James,

    Thank you for sharing your example.

    We should look at POC indication on a case by case.  A lot of IVDs have been cleared for both POC and clinical settings, meaning that if a use in clinical setting was cleared first and the firm could rely on the data contained in the original 510(k) to expand POC indication.  

    But It is not always the case. 

    Noemi's post reminds us of the importance of regulatory plan/planning ahead with awareness to begin with. 

    D



    Original Message


  • 9.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 07:14

    Just fought this issue with OIR on behalf of a client and had to appeal to Dr. Maisel to get it resolved.  They will most likely take the position it is a major change to the intended use requiring a traditional 510(k) and supported by new data.  Depends a bit more on your facts which may make it a closer call.  

    Mark DuVal, J.D, FRAPS


    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 10.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 14:32
    Hi Mark,

    If I am in your shoes, I would pick such a fight unless facts are compelling.

    David



    Original Message


  • 11.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 14:39
    Hi Mark,

    My main reasons why I wouldn't pick such a fight is because it is so obvious!

    There are many firms intending to fight with FDA over minor issues. Firms should be adequately advised not to fight when the issues and facts are obvious. 

    I am not implying that your appeal is frivolous in any way. 

    D



    Original Message


  • 12.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 10-Mar-2017 12:52

    David that's your typical reaction to every one of my entries-relax J.  Sometimes you don't know the full facts of how our clients come into the door, e.g. warning letter and it's not always as simple  or as "obvious" as you think.  And sometimes the stakes for the client are a lot higher than you realize.  In the end I gave her the same advice.  I wouldn't choose the fight either, but when you are a regulatory lawyer sometimes it is brought to you that way.  I think we should just comment without seeking to demean or attack one another. I like your stuff, try to fine the good in mine.  After all we've had 750 clients in 13 years and we must be doing something right...

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

    duval@duvalfdalaw.com 

    www.duvalfdalaw.com

     

    facebook icontwitter iconlinkedin icon

     




    Original Message


  • 13.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 10-Mar-2017 13:39
    Hi Mark,

    Thank you for your respectful comment.  I didn't mean to undermine your client's case in any way.

    In fact, I got the sense that the client may have received a warning letter because of recent use, the use of which has not been cleared.  You are fighting for the client going through appeal - great work for the client.  One recent case for an appeal (Regen as further described below) reminds us of many lessons to seriously consider before taking an appeal. 

    I've seen many firms complaining to the FDA and I also have seen many FDA folks emotionally dealing with firms. I know many of CDRHers current and past.

    Having seen and known how the matters can be handled at the CDRH, industry may rather end up wasting resources than saving them. 

    A great thing now is that CDRH managers are rather willing to avoid costly legal disputes not at all cost but with big efforts.  More than ever, if a firm takes an offensive position and goes through an appeal with a retained lawyer (at the CDRH level), it is more likely to get the matter resolved than ever before.

    A case example: Back in 2008, I had expected how the ReGen case would develop starting in 2008. It went wrong directions. It couldn't have been worse at the end. The issue was really simple back then and got developed into such a mess over the next few years leading to an official investigation, rescinding the cleared 510(k)! 

    At the end, I hope all stakeholders (industry and FDAers) choose to remain reasonable! I also hope your appeal goes well!

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 14.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 12-Mar-2017 23:45

    Agree with you David.  I am at FDA with clients 3 to 4 times per month and most are very collaborative Pre-subs, discussing clinical trial and performance data requirements and the regulatory pathway.  We are on the phone and email non-stop with the Agency and we have great relationships.  We don't have to fight on many cases.  We mostly work with our colleagues at FDA very respectfully.  I enjoy my relationships there.  Like you, it's our stock-in-trade.   

     

    Mark

     

     

    DuVal-signature version

     

    Mark DuVal, J.D., FRAPS

    President & CEO, DuVal & Associates, P.A.

    Suite 1820, Medical Arts Building, 825 Nicollet Mall

    Minneapolis, MN 55402

    Office:  612.338.7170 Cell:  612-325-9074 - Fax:  612.455.0665

    duval@duvalfdalaw.com 

    www.duvalfdalaw.com

     

    facebook icontwitter iconlinkedin icon

     




    Original Message


  • 15.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 13-Mar-2017 16:26
    Hi Mark,

    Thank you for sharing further info on your practice. 

    You may want to expand your practice areas to FDA/CBER and FDA/CDER, folks of which tend to be a bit more collegial and professional in my opinion.

    You may refer to me any prospective investor(s) who need some critical assessment for investment decisions regarding certain technology, private or public companies. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 16.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 14-Mar-2017 07:25
    Good to know the other things you do David.  I know what you mean about CBER  and CBER.  For 15 years I was general counsel to 3M Pharmaceuticals and 3M Drug Delivery Systems (with a year in Europe) and I dealt with them a lot.  Also had 3 medical device divisions during that time.  I recognize a few other 3Mers like Ginger Cantor on line.  She is a first class regger.  

    Mark DuVal, J.D., FRAPS



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 17.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 14:29
    Noemi,

    When user environments get changed (e.g., POC), it is worth considering what changes would occur.

    For POC indication, a larger number of tests would be expected. 

    To best reflect user environment settings (POC), FDA is likely to recommend larger tests with few more operators to be included. 

    Otherwise, many firms would try to get POC indication for their devices. Wouldn't you? I would.  

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.



    Original Message


  • 18.  RE: Does a change in Intended Use to previous IVD 510(k) submission

    Posted 09-Mar-2017 14:47
    As a bunch of people have already expressed, a new 510(k) is necessary. Point of Care indications are considered changes to the intended use and they also trip statutes specifically laid out in 21 CFR 862.9(c)(9). There is significant (in FDA language) extra analysis and data required for a POC indication. However, you can leverage most of the testing from the original 510(k), just include justifications for that leveraging. Finally, there is no reason to change the name of the device for the submission other than to clarify the old submission from the new. The FDA pre-market review doesn't care what name is used and plenty of companies change the device name after 510(k) approval (this makes the 510(k) database difficult to navigate sometimes).

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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    Original Message


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