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  • 1.  Who "owns" the 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 22-Jun-2017 10:40
    This message was posted by a user wishing to remain anonymous

    ​

    I am preparing a premarket (510(k)) submission to demonstrate substantial equivalence of an IVD assay and the instrument that the assay is required to run on. The instrument is manufactured onsite by the biotech, but because of limited resources, the assay may need to be manufactured offsite by a vendor.  Will sourcing out the manufacture of the assay change the "ownership" of the 510(k) since it the assay that is being submitted to demonstrate substantial equivalence?  Should the biotech manufacture the assay that will be used during the clinical study for FDA submission?



  • 2.  RE: Who "owns" the 510(k)?

    Posted 22-Jun-2017 11:12
    Keep in mind that the 510(k) owner has very little to do with who physically manufacturers the device. It is very common for companies to own the design and 510(k) but utilize OEMs to actually manufacture the device, rather than make it themselves.

    I am having to make a few assumptions here, but I am assuming that "the biotech" developed the "system" of using the equipment and the assay, and has been responsible for the designs and testing. As such, I would expect them to submit and own the 510(k) regardless of who physically makes the assay.

    Putting my quality hat on though, you should make clear who is responsible for what, including submissions (and complaints/MDR filing, recall decision making etc etc), in your quality agreement with the vendor who will be making the assay.

    g-

    ------------------------------
    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


  • 3.  RE: Who "owns" the 510(k)?

    Posted 23-Jun-2017 06:40
    Based on the information provided, I agree with Ginger's general assessment.  It would appear that the manufacturer of the assay is no more than a contract manufacturer to the 510(k) holder which would include both the equipment and assay.  Keep in mind that the contract manufacturer has to list as such.  The details of responsibilities should be in the Quality Agreement between the firms.





    Original Message


  • 4.  RE: Who "owns" the 510(k)?

    Posted 23-Jun-2017 06:53
    Well said Ginger, and FDA upon inspection will hold the owner, as a "specification developer," responsible for the full quality system including that of the contract manufacturer.  

    Mark DuVal, J.D., FRAPS
    DuVal & Associates, P.A. 



    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 5.  RE: Who "owns" the 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jun-2017 12:03
    This message was posted by a user wishing to remain anonymous

    ​Thank you ALL for your excellent responses!!  (Sorry that I can't post with my name, but I'm bound by confidentiality and my name could be linked to my company...)
    Original Message


  • 6.  RE: Who "owns" the 510(k)?

    Posted 23-Jun-2017 04:17
    As a further point, you should always include within the 510(k) identification of the 510(k) owner, 510(k) submitter and 510(k) application correspondent. These may all be the same, but they may also all be different, so it's important to make the responsibilities clear.

    Roger

    ------------------------------
    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Consulting
    Rome, Italy
    +39 06 578 2665
    rgray@donawa.com
    ------------------------------

    Original Message


  • 7.  RE: Who "owns" the 510(k)?

    Posted 23-Jun-2017 09:04
    Dear A:

    I've seen 510(k) ownership disputes. 

    Between parties ((legal) manufacturer, OEM, CMO or specification developer), legal ownership (510(k) holder who possesses 510(k) clearance) can be arranged in a contract including Quality Agreement.

    FDA recently issued Final Rule, effective as of 2012-10-01, on Device Registration and Listing requirements to better reflect the statutory amendments made to the FDCA. 21 CFR 807 has accordingly been modified. 

    To be in compliance with the statutory provisions, legal ownership arrangement should be made with awareness as follows.

    - when a listing of a device is created by a (legal) owner or operator*, 510(k) number must be included.
    - *: A legal owner or operator can be any party (as a manufacturer, reprocessor, remanufacturer, repacker/relabeler, specification developer, etc.)
    - The listing signals to FDA who is responsible for the commercial distribution of the device as the current 510(k) holder. 

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    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.





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  • 8.  RE: Who "owns" the 510(k)?

    Posted 24-Jun-2017 09:10
    ​David beat me to it.

    Back when I was new at this, I agreed to prepare and submit 510(k)s for a non-US firm who wanted to market their product in the US. I had them all written, copies made, ready to go when I got a phone call. They had found an exclusive licensed distributor who had agreed to submit the 510(k) and act as if the non-US firm was a contract manufacturer. My client wanted to do it to save the cost of the 510(k). Plus, the champion of the project at the US firm was an ex-employee of FDA, and the submissions would end up on the desk of his successor.

    I wasn't in a position to tell my client what to do so I went along with it and accompanied the process. It did not go as smoothly as one might have thought given the fact that the project champion supposedly had an "in" at the agency. But eventually all four 510(k)s received an SE.

    Fast forward five years. I get a phone call from the client. The project champion has unexpectedly passed away, no one else at his firm has any interest in importing / distributing the product. My client can't sell their own products in the US unless they get clearance using their own products as predicates. That, or take the US firm up on their offer to sell them the 510(k) rights for $25k apiece.

    Since then I've seen a lot of manufacturer /distributor relationships go south (in some cases creating problems with FURLS accounts) and I've modified the advice I give clients accordingly.:)

    ------------------------------
    Jean Bigoney PHD, RAC
    Managing Member
    Nu Device Consulting LLC
    Murphy NC
    United States
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    Original Message


  • 9.  RE: Who "owns" the 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jun-2017 11:16
    This message was posted by a user wishing to remain anonymous

    ​Thank you Jean sounds like it was quite a nightmare!  And again thank you all for your great responses; I will take all the advice given.
    Original Message


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